FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 12971328 · Received December 9, 2021

Report

Report Number
2182207-2021-02138
Event Type
Injury
Date Received
December 9, 2021
Date of Event
January 1, 2020
Report Date
December 9, 2021
Manufacturer
MEDTRONIC NEUROMODULATION
Product Code
LKK
PMA / PMN Number
P860004
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 0

OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL/LOT #: UNKNOWN, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 0

CITATION:ROTH J, AGHA H, DAVIS C. BACLOFEN BRIDGING, WEANING PROTOCOL AND PAIN MANAGEMENT OF A PERSON WITH T6 PARAPLEGIA WHO REQUIRED REMOVAL OF INTRATHECAL BACLOFEN PUMP DUE TO WOUND INFECTION. BMJ CASE REP. 2021;14(9).10.1136/BCR-2021-242686. SUMMARY: INTRATHECAL BACLOFEN IS RECOGNISED AS AN EFFECTIVE TREATMENT OPTION FOR SEVERE SYMPTOMS OF SEGMENTAL SPASTICITY AFTER SPINAL CORD INJURY. WE PRESENT OUR EXPERIENCE OF A CASE OF A PATIENT WHO WAS ADMITTED TO OUR CENTRE FOR ELECTIVE INTRATHECAL BACLOFEN PUMP REVISION SURGERY, BUT POSTSURGICAL COMPLICATIONS OF A BLOCKED CATHETER AND SUBSEQUENT WOUND INFECTIONS MEANT THE PUMP HAD TO BE REMOVED. IN THIS CASE, TREATMENT OF SEVERE SPASTICITY AND NOCICEPTIVE PAIN WAS REQUIRED WHILE AVOIDING POTENTIALLY LETHAL SIDE EFFECTS OF SUDDEN BACLOFEN WITHDRAWAL. WE SUGGEST AN EFFECTIVE BRIDGING AND WEANING PROTOCOL FOR ORAL DRUG TITRATION TO TREAT SPASTICITY AND PAIN AS A BLENDED SYNDROME IN THIS CHALLENGING SITUATION. REPORTED EVENTS: CASE PRESENTATION A (B)(6) MAN SUSTAINED A TRAUMATIC SCI IN 2010 AFTER FALLING APPROXIMATELY 40 FT FROM A WINDOW. HE WAS PREVIOUSLY WELL WITH NO SIGNIFICANT PREVIOUS MEDICAL HISTORY. HE SUFFERED A T8 VERTEBRAL FRACTURE AND C5/6 INTERVERTEBRAL DISC DISPLACEMENT WITH CORD COMPR ESSION. HE UNDERWENT SURGICAL FIXATION AT A MAJOR LONDON HOSPITAL. AS THERE WAS NO SENSATION BELOW THE LEVEL OF THE INJURY, HIS INJURY WAS CLASSIFIED AS T6 COMPLETE PARAPLEGIA. DURING THE FORTHCOMING 3 YEARS AS AN OUTPATIENT, HE REPORTED ONGOING SEVERE SPASTICITY CHARACTERIZED BY PAINFUL LEG SPASMS FREQUENT OVER A 24 HOUR PERIOD. HIS SCI WAS RECLASSIFIED AS INCOMPLETE AS HE HAD RECOVERED SENSATION TO DEEP ANAL PRESSURE. THE SPASM FREQUENCY AND MAGNITUDE WERE UNRESPONSIVE TO CONSERVATIVE MEASURES (PHYSIOTHERAPY AND MINDFULNESS INTERVENTIONS) AND ADMINISTRATION OF ORAL ANTISPASTICITY MANAGEMENT INCLUDING BACLOFEN, TIZANIDINE AND BENZODIAZEPINES. INTERESTINGLY, HE DESCRIBED HIS NEUROPATHIC PAIN PERCEPTION AT THIS STAGE AS WELL CONTROLLED, ALTHOUGH HE WAS NOT TREATED WITH GABAPENTINOIDS OR OPIOIDS. A TRIAL OF AMITRIPTYLINE DID NOT REDUCE HIS PERCEPTION OF DISCOMFORT FROM SPASMS. TREATMENT ITB TREATMENTS AND REVISIONS THE PATIENT HAD HIS FIRST PUMP INSERTED IN 2013; A MEDTRONIC SYNCHROMED II PUMP. THIS GREATLY IMPROVED HIS SPASMS FOR THE FOLLOWING 6 YEARS AND HE ENJOYED A PERIOD OF STABLE SYMPTOMS. IN 2020, HE UNDERWENT ROUTINE ELECTIVE REVISION OF THE BACLOFEN PUMP DUE TO PREDICTABLE BATTERY FAILURE. NO INTRAOPERATIVE COMPLICATIONS WERE EXPERIENCED AND HE WAS DISCHARGED FOR OUTPATIENT FOLLOW-UP. AFTER SEVERAL WEEKS, HE CONTACTED THE REHABILITATION CENTRE WITH WORSENING PAINFUL ABDOMINAL AND LOWER LIMB SPASMS, BUT NO OTHER MEDICAL CONCERNS OR NOXIOUS STIMULI IDENTIFIED. HE WAS READMITTED UNDER THE REHABILITATION TEAM 6 WEEKS AFTER HIS SURGERY, FOR A MULTIDISCIPLINARY REVIEW INTO POSSIBLE CAUSES. A TRIAL OF A HIGHER BOLUS DOSE OF ITB WAS ADMINISTERE, AN INCREASE IN 20% ORIGINAL DOSE (374.6¿G/24 HOURS FROM STARTING DOSE 309.3 ¿G/24 HOURS). HOWEVER, THERE WAS NO CHANGE IN EITHER SPASMS OR PAIN PERCEPTION. IT WAS CONCLUDED THAT THE CATHETER WAS BLOCKED AND HE UNDERWENT A SURGICAL PUMP REPLACEMENT ((B)(6) 2020). FLUCLOXACILLIN AND GENTAMICIN WERE USED AS PROPHYLACTIC ANTIBIOTICS ON THIS OCCASION. AFTER DISCHARGE, HE DEVELOPED A SURGICAL WOUND INFECTION REQUIRING READMISSION FOR THE THIRD TIME FOR A WOUND WASHOUT AND DEBRIDEMENT. PROPHYLACTIC GENTAMICIN WAS USED PRIOR TO SURGERY. TISSUE CULTURES GREW STAPH EPIDERMIS AND CORYNEBACTERIUM AMYCOLATUM. INTRAVENOUS TEICOPLANIN WAS STARTED BEFORE SWITCHING TO ORAL LINEZOLID FOR A FURTHER 2 WEEKS (3 WEEKS TOTAL). HE WAS DISCHARGED HOME. THREE WEEKS LATER, HE WAS READMITTED A FINAL TIME AFTER DEVELOPING A FEVER AND PURULENT DISCHARGE FROM THE ANTERIOR ABDOMINAL WOUND. THE MULTIDISCIPLINARY TEAM (REHABILITATION, SURGERY AND MICROBIOLOGY) AGREED THAT THE BEST SOLUTION WAS TO REMOVE THE PUMP. DUE TO THE ONGOING INFECTION, IT WAS DEEMED TOO RISKY TO INSERT A NEW PUMP. THE OPERATION WAS CHALLENGED BY THE FACT THAT THERE WAS SIGNIFICANT DIFFICULTY REMOVING THE INTERNAL CATHETER UNDER TENSION IN THE INTRATHECAL SPACE. THE EXTERNAL CATHETER TIP WAS, THEREFORE, LIGATED AND THE REST OF THE CATHETER ARTEFACT REMAINED IN SITU. SUPERFICIAL AND DEEP WOUND TISSUE CULTURES GREW (B)(6), KLEBSIELLA PNEUMONIA, SERRATIA MARCESCENS AND CITROBACTER KOSERI. HE COMMENCED INTRAVENOUS ANTIBIOTICS CONSISTING OF MEROPENUM (LATER SWITCHED TO ERTAPENUM) AND TEICOPLANIN. THESE WERE CONVERTED TO ORAL ANTIBIOTICS (DOXYCYCLINE AND COTRIMOXAZOLE) ON HIS DISCHARGE, WITH THE TOTAL COURSE BEING 12 WEEKS. HE CURRENTLY REMAINS WITHOUT A PUMP BUT IS KEEN TO REINSTATE THE DEVICE FOR SPASTICITY RELIEF DESPITE PREVIOUS COMPLICATIONS. BACLOFEN BRIDGING AND WEANING PROTOCOL AND PAIN MANAGEMENT THREE DAYS PRIOR TO SURGICAL PUMP REMOVAL, THE ITB DOSE WAS DECREASED BY 10% (374.6 ¿G/24 HOURS TO 337.2 ¿G/24 HOURS) AND THE BRIDGING PROCESS WAS COMMENCED, WITH ORAL BACLOFEN AT 30 MG THREE TIMES PER DAY AND 250 ¿G CLONAZEPAM NIGHTLY FOR BREAKTHROUGH SPASMS (SEE TABLE 1). THE FOLLOWING DAY, THE ITB DOSE WAS REDUCED BY A FURTHER 20% (TO 268.9 ¿G/24 HOURS).THE DOSE WAS SET AS A RATE FOR A PATIENT WHO WAS NOT PREVIOUSLY BACLOFEN-NAÏVE, AND HE WAS COUNSELLED ON THE POSSIBLE SIDE EFFECTS OF ORAL TREATMENT SUCH AS DROWSINESS AND CONFUSION, DRY MOUTH, NAUSEA AND HEADACHE. USE OF A BENZODIAZEPINE HAD A DOUBLE ACTION FOR SPASTICITY AND ALSO TO BRIDGE THE POSSIBLE REDUCTION IN THE SEIZURE THRESHOLD THAT WOULD BE EXPERIENCED WITH THE ORAL DOSE OF BACLOFEN. ON THE DAY OF FINAL PUMP REMOVAL, THE FREQUENCY OF ORAL BACLOFEN WAS INCREASED, AND CLONAZEPAM WAS INCREASED. TIZANIDINE WAS ALSO STARTED AT 2 MG TWO TIMES PER DAY. THERE WOULD, THEREFORE, BE SCOPE TO INCREASE ORAL BACLOFEN AND/OR TIZANIDINE AT A LATER DATE. AFTER SURGERY, A 1% INTRAVENOUS PROPOFOL INFUSION WAS STARTED TO BRIDGE THE PATIENT FOR POTENTIAL SEIZURES, STARTING AT 20 MG/HOUR ALONGSIDE THE ORAL MEDICATIONS. TIZANIDINE WAS INCREASED POSTOPERATIVELY TO 4 MG FOUR TIMES PER DAY. THE INTRAVENOUS PROPOFOL INFUSION WAS GRADUALLY TITRATED OVER THE NEXT 48 HOURS IN INCREMENTS OF 10 MG/HOUR UNTIL A FINAL DOSE OF 60 MG/HOUR. WHILE IN INTENSIVE CARE, WITHIN 12 HOURS OF HIS OPERATION, HIS SPASMS BECAME MORE SEVERE. ALTHOUGH HE WAS NOT REPORTING EXPLICITLY OF PAIN AT THIS STAGE, HE WAS PRESCRIBED REGULAR ANALGESIA POSTOPERATIVELY ON HIS DRUG CHART, ACCORDING TO THE NICE GUIDELINES ON PERIOPERATIVE CARE IN ADULTS .3 PARACETAMOL AND TRAMADOL WERE ADMINISTERED. THE DOSE WAS RAPIDLY INCREASED FROM 50 MG AS REQUIRED TO 100 MG REGULARLY FOUR TIMES PER DAY. THE NOCICEPTIVE PAIN AND SPASMS BECAME MUCH MORE MANAGEABLE AND SLEEP WAS NO LONGER ELUSIVE. STRONG OPIATES WERE NEVER REQUIRED. THE PATIENT¿S SPASMS BECAME MORE CONTROLLED AND THE CLONAZEPAM WAS REDUCED AND USED WHEN REQUIRED. TWO DAYS LATER, THE PATIENT WAS RAPIDLY WEANED OFF THE PROPOFOL INFUSION. OUTCOME AND FOLLOW-UP PROGRESS OF REHABILITATION POSTPUMP REMOVAL ON RETURN TO THE REHABILITATION UNIT, POSITIONAL FACTORS REMAINED IMPORTANT TRIGGERS FOR PAINFUL SPASMS. LYING FLAT WITH HIPS EXTENDED TENDED TO TRIGGER ABDOMINAL AND HIP FLEXOR SPASMS, WHICH WERE VERY UNCOMFORTABLE. THESE WERE SIGNIFICANTLY REDUCED WITH THE USE OF A T-ROLL SUPPORT AND A PASSIVE STRETCHING PROGRAMME TO THE LOWER LIMBS WITH FEET IN FULL DORSIFLEXION. AS HIS SURGICAL WOUNDS HEALED AND HIS IMMEDIATE NOCICEPTIVE PAIN SUBSIDED WITH TRAMADOL, HE SELF-DIRECTED A WEANING PROGRAMME FOR THIS. THE PATIENT FOUND THAT TRAMADOL CAUSED A SUBJECTIVE SLOWING OF MENTAL FACULTIES, A SIDE-EFFECT HE FOUND UNACCEPTABLE. AS THERE WERE NO NEUROPATHIC FEATURES OF THIS PAIN, HE DID NOT REQUIRE ADDITIONAL GABAPENTINOIDS. FOCAL SPASTICITY TO THE HIP FLEXORS WAS TREATED WITH BOTULINUM TOXIN A (DYSPORT IS USED IN THIS CENTRE) TO HIS HIP FLEXORS BILATERALLY. ANY INTERFACE WITH NEUROGENIC BLADDER SPASMS OR VISCERAL DISCOMFORT WAS TREATED WITH OXYBUTYNIN. ON DISCHARGE, HIS ONLY MEDICATION FROM THE REHABILITATION UNIT WAS TRAMADOL 50 MG AS REQUIRED, WHICH HE CONTINUED TO WEAN. CLONAZEPAM WAS ONLY OCCASIONALLY USED AS REQUIRED FOR BREAKTHROUGH SPASMS, THE FREQUENCY OF WHICH CONTINUED TO REDUCE. THE MULTIDISCIPLINARY INPATIENT TREATMENT PLAN WAS SO SUCCESSFUL THAT THE TEAM PLAN TO WEAN TIZANIDINE ORALLY IN DUE COURSE AS AN OUTPATIENT, ACCORDING TO THE PATIENT¿S REPORTED SEVERITY OF SPASTICITY WHILE AT HOME. LIAISON WITH THE SPINAL SURGICAL TEAM WAS ONGOING REGARDING INSTALLATION OF A NEW BACLOFEN PUMP, A PROCEDURE THE PATIENT IS KEEN TO UNDERGO.

Description of Event or Problem · 0

CITATION:ROTH J, AGHA H, DAVIS C. BACLOFEN BRIDGING, WEANING PROTOCOL AND PAIN MANAGEMENT OF A PERSON WITH T6 PARAPLEGIA WHO REQUIRED REMOVAL OF INTRATHECAL BACLOFEN PUMP DUE TO WOUND INFECTION. BMJ CASE REP. 2021;14(9).10.1136/BCR-2021-242686. SUMMARY: INTRATHECAL BACLOFEN IS RECOGNISED AS AN EFFECTIVE TREATMENT OPTION FOR SEVERE SYMPTOMS OF SEGMENTAL SPASTICITY AFTER SPINAL CORD INJURY. WE PRESENT OUR EXPERIENCE OF A CASE OF A PATIENT WHO WAS ADMITTED TO OUR CENTRE FOR ELECTIVE INTRATHECAL BACLOFEN PUMP REVISION SURGERY, BUT POSTSURGICAL COMPLICATIONS OF A BLOCKED CATHETER AND SUBSEQUENT WOUND INFECTIONS MEANT THE PUMP HAD TO BE REMOVED. IN THIS CASE, TREATMENT OF SEVERE SPASTICITY AND NOCICEPTIVE PAIN WAS REQUIRED WHILE AVOIDING POTENTIALLY LETHAL SIDE EFFECTS OF SUDDEN BACLOFEN WITHDRAWAL. WE SUGGEST AN EFFECTIVE BRIDGING AND WEANING PROTOCOL FOR ORAL DRUG TITRATION TO TREAT SPASTICITY AND PAIN AS A BLENDED SYNDROME IN THIS CHALLENGING SITUATION. REPORTED EVENTS: CASE PRESENTATION A (B)(6) MAN SUSTAINED A TRAUMATIC SCI IN 2010 AFTER FALLING APPROXIMATELY 40 FT FROM A WINDOW. HE WAS PREVIOUSLY WELL WITH NO SIGNIFICANT PREVIOUS MEDICAL HISTORY. HE SUFFERED A T8 VERTEBRAL FRACTURE AND C5/6 INTERVERTEBRAL DISC DISPLACEMENT WITH CORD COMPR ESSION. HE UNDERWENT SURGICAL FIXATION AT A MAJOR LONDON HOSPITAL. AS THERE WAS NO SENSATION BELOW THE LEVEL OF THE INJURY, HIS INJURY WAS CLASSIFIED AS T6 COMPLETE PARAPLEGIA. DURING THE FORTHCOMING 3 YEARS AS AN OUTPATIENT, HE REPORTED ONGOING SEVERE SPASTICITY CHARACTERIZED BY PAINFUL LEG SPASMS FREQUENT OVER A 24 HOUR PERIOD. HIS SCI WAS RECLASSIFIED AS INCOMPLETE AS HE HAD RECOVERED SENSATION TO DEEP ANAL PRESSURE. THE SPASM FREQUENCY AND MAGNITUDE WERE UNRESPONSIVE TO CONSERVATIVE MEASURES (PHYSIOTHERAPY AND MINDFULNESS INTERVENTIONS) AND ADMINISTRATION OF ORAL ANTISPASTICITY MANAGEMENT INCLUDING BACLOFEN, TIZANIDINE AND BENZODIAZEPINES. INTERESTINGLY, HE DESCRIBED HIS NEUROPATHIC PAIN PERCEPTION AT THIS STAGE AS WELL CONTROLLED, ALTHOUGH HE WAS NOT TREATED WITH GABAPENTINOIDS OR OPIOIDS. A TRIAL OF AMITRIPTYLINE DID NOT REDUCE HIS PERCEPTION OF DISCOMFORT FROM SPASMS. TREATMENT ITB TREATMENTS AND REVISIONS THE PATIENT HAD HIS FIRST PUMP INSERTED IN 2013; A MEDTRONIC SYNCHROMED II PUMP. THIS GREATLY IMPROVED HIS SPASMS FOR THE FOLLOWING 6 YEARS AND HE ENJOYED A PERIOD OF STABLE SYMPTOMS. IN 2020, HE UNDERWENT ROUTINE ELECTIVE REVISION OF THE BACLOFEN PUMP DUE TO PREDICTABLE BATTERY FAILURE. NO INTRAOPERATIVE COMPLICATIONS WERE EXPERIENCED AND HE WAS DISCHARGED FOR OUTPATIENT FOLLOW-UP. AFTER SEVERAL WEEKS, HE CONTACTED THE REHABILITATION CENTRE WITH WORSENING PAINFUL ABDOMINAL AND LOWER LIMB SPASMS, BUT NO OTHER MEDICAL CONCERNS OR NOXIOUS STIMULI IDENTIFIED. HE WAS READMITTED UNDER THE REHABILITATION TEAM 6 WEEKS AFTER HIS SURGERY, FOR A MULTIDISCIPLINARY REVIEW INTO POSSIBLE CAUSES. A TRIAL OF A HIGHER BOLUS DOSE OF ITB WAS ADMINISTERE, AN INCREASE IN 20% ORIGINAL DOSE (374.6¿G/24 HOURS FROM STARTING DOSE 309.3 ¿G/24 HOURS). HOWEVER, THERE WAS NO CHANGE IN EITHER SPASMS OR PAIN PERCEPTION. IT WAS CONCLUDED THAT THE CATHETER WAS BLOCKED AND HE UNDERWENT A SURGICAL PUMP REPLACEMENT ((B)(6) 2020). FLUCLOXACILLIN AND GENTAMICIN WERE USED AS PROPHYLACTIC ANTIBIOTICS ON THIS OCCASION. AFTER DISCHARGE, HE DEVELOPED A SURGICAL WOUND INFECTION REQUIRING READMISSION FOR THE THIRD TIME FOR A WOUND WASHOUT AND DEBRIDEMENT. PROPHYLACTIC GENTAMICIN WAS USED PRIOR TO SURGERY. TISSUE CULTURES GREW STAPH EPIDERMIS AND CORYNEBACTERIUM AMYCOLATUM. INTRAVENOUS TEICOPLANIN WAS STARTED BEFORE SWITCHING TO ORAL LINEZOLID FOR A FURTHER 2 WEEKS (3 WEEKS TOTAL). HE WAS DISCHARGED HOME. THREE WEEKS LATER, HE WAS READMITTED A FINAL TIME AFTER DEVELOPING A FEVER AND PURULENT DISCHARGE FROM THE ANTERIOR ABDOMINAL WOUND. THE MULTIDISCIPLINARY TEAM (REHABILITATION, SURGERY AND MICROBIOLOGY) AGREED THAT THE BEST SOLUTION WAS TO REMOVE THE PUMP. DUE TO THE ONGOING INFECTION, IT WAS DEEMED TOO RISKY TO INSERT A NEW PUMP. THE OPERATION WAS CHALLENGED BY THE FACT THAT THERE WAS SIGNIFICANT DIFFICULTY REMOVING THE INTERNAL CATHETER UNDER TENSION IN THE INTRATHECAL SPACE. THE EXTERNAL CATHETER TIP WAS, THEREFORE, LIGATED AND THE REST OF THE CATHETER ARTEFACT REMAINED IN SITU. SUPERFICIAL AND DEEP WOUND TISSUE CULTURES GREW (B)(6), KLEBSIELLA PNEUMONIA, SERRATIA MARCESCENS AND CITROBACTER KOSERI. HE COMMENCED INTRAVENOUS ANTIBIOTICS CONSISTING OF MEROPENUM (LATER SWITCHED TO ERTAPENUM) AND TEICOPLANIN. THESE WERE CONVERTED TO ORAL ANTIBIOTICS (DOXYCYCLINE AND COTRIMOXAZOLE) ON HIS DISCHARGE, WITH THE TOTAL COURSE BEING 12 WEEKS. HE CURRENTLY REMAINS WITHOUT A PUMP BUT IS KEEN TO REINSTATE THE DEVICE FOR SPASTICITY RELIEF DESPITE PREVIOUS COMPLICATIONS. BACLOFEN BRIDGING AND WEANING PROTOCOL AND PAIN MANAGEMENT THREE DAYS PRIOR TO SURGICAL PUMP REMOVAL, THE ITB DOSE WAS DECREASED BY 10% (374.6 ¿G/24 HOURS TO 337.2 ¿G/24 HOURS) AND THE BRIDGING PROCESS WAS COMMENCED, WITH ORAL BACLOFEN AT 30 MG THREE TIMES PER DAY AND 250 ¿G CLONAZEPAM NIGHTLY FOR BREAKTHROUGH SPASMS (SEE TABLE 1). THE FOLLOWING DAY, THE ITB DOSE WAS REDUCED BY A FURTHER 20% (TO 268.9 ¿G/24 HOURS).THE DOSE WAS SET AS A RATE FOR A PATIENT WHO WAS NOT PREVIOUSLY BACLOFEN-NAÏVE, AND HE WAS COUNSELLED ON THE POSSIBLE SIDE EFFECTS OF ORAL TREATMENT SUCH AS DROWSINESS AND CONFUSION, DRY MOUTH, NAUSEA AND HEADACHE. USE OF A BENZODIAZEPINE HAD A DOUBLE ACTION FOR SPASTICITY AND ALSO TO BRIDGE THE POSSIBLE REDUCTION IN THE SEIZURE THRESHOLD THAT WOULD BE EXPERIENCED WITH THE ORAL DOSE OF BACLOFEN. ON THE DAY OF FINAL PUMP REMOVAL, THE FREQUENCY OF ORAL BACLOFEN WAS INCREASED, AND CLONAZEPAM WAS INCREASED. TIZANIDINE WAS ALSO STARTED AT 2 MG TWO TIMES PER DAY. THERE WOULD, THEREFORE, BE SCOPE TO INCREASE ORAL BACLOFEN AND/OR TIZANIDINE AT A LATER DATE. AFTER SURGERY, A 1% INTRAVENOUS PROPOFOL INFUSION WAS STARTED TO BRIDGE THE PATIENT FOR POTENTIAL SEIZURES, STARTING AT 20 MG/HOUR ALONGSIDE THE ORAL MEDICATIONS. TIZANIDINE WAS INCREASED POSTOPERATIVELY TO 4 MG FOUR TIMES PER DAY. THE INTRAVENOUS PROPOFOL INFUSION WAS GRADUALLY TITRATED OVER THE NEXT 48 HOURS IN INCREMENTS OF 10 MG/HOUR UNTIL A FINAL DOSE OF 60 MG/HOUR. WHILE IN INTENSIVE CARE, WITHIN 12 HOURS OF HIS OPERATION, HIS SPASMS BECAME MORE SEVERE. ALTHOUGH HE WAS NOT REPORTING EXPLICITLY OF PAIN AT THIS STAGE, HE WAS PRESCRIBED REGULAR ANALGESIA POSTOPERATIVELY ON HIS DRUG CHART, ACCORDING TO THE NICE GUIDELINES ON PERIOPERATIVE CARE IN ADULTS .3 PARACETAMOL AND TRAMADOL WERE ADMINISTERED. THE DOSE WAS RAPIDLY INCREASED FROM 50 MG AS REQUIRED TO 100 MG REGULARLY FOUR TIMES PER DAY. THE NOCICEPTIVE PAIN AND SPASMS BECAME MUCH MORE MANAGEABLE AND SLEEP WAS NO LONGER ELUSIVE. STRONG OPIATES WERE NEVER REQUIRED. THE PATIENT¿S SPASMS BECAME MORE CONTROLLED AND THE CLONAZEPAM WAS REDUCED AND USED WHEN REQUIRED. TWO DAYS LATER, THE PATIENT WAS RAPIDLY WEANED OFF THE PROPOFOL INFUSION. OUTCOME AND FOLLOW-UP PROGRESS OF REHABILITATION POSTPUMP REMOVAL ON RETURN TO THE REHABILITATION UNIT, POSITIONAL FACTORS REMAINED IMPORTANT TRIGGERS FOR PAINFUL SPASMS. LYING FLAT WITH HIPS EXTENDED TENDED TO TRIGGER ABDOMINAL AND HIP FLEXOR SPASMS, WHICH WERE VERY UNCOMFORTABLE. THESE WERE SIGNIFICANTLY REDUCED WITH THE USE OF A T-ROLL SUPPORT AND A PASSIVE STRETCHING PROGRAMME TO THE LOWER LIMBS WITH FEET IN FULL DORSIFLEXION. AS HIS SURGICAL WOUNDS HEALED AND HIS IMMEDIATE NOCICEPTIVE PAIN SUBSIDED WITH TRAMADOL, HE SELF-DIRECTED A WEANING PROGRAMME FOR THIS. THE PATIENT FOUND THAT TRAMADOL CAUSED A SUBJECTIVE SLOWING OF MENTAL FACULTIES, A SIDE-EFFECT HE FOUND UNACCEPTABLE. AS THERE WERE NO NEUROPATHIC FEATURES OF THIS PAIN, HE DID NOT REQUIRE ADDITIONAL GABAPENTINOIDS. FOCAL SPASTICITY TO THE HIP FLEXORS WAS TREATED WITH BOTULINUM TOXIN A (DYSPORT IS USED IN THIS CENTRE) TO HIS HIP FLEXORS BILATERALLY. ANY INTERFACE WITH NEUROGENIC BLADDER SPASMS OR VISCERAL DISCOMFORT WAS TREATED WITH OXYBUTYNIN. ON DISCHARGE, HIS ONLY MEDICATION FROM THE REHABILITATION UNIT WAS TRAMADOL 50 MG AS REQUIRED, WHICH HE CONTINUED TO WEAN. CLONAZEPAM WAS ONLY OCCASIONALLY USED AS REQUIRED FOR BREAKTHROUGH SPASMS, THE FREQUENCY OF WHICH CONTINUED TO REDUCE. THE MULTIDISCIPLINARY INPATIENT TREATMENT PLAN WAS SO SUCCESSFUL THAT THE TEAM PLAN TO WEAN TIZANIDINE ORALLY IN DUE COURSE AS AN OUTPATIENT, ACCORDING TO THE PATIENT¿S REPORTED SEVERITY OF SPASTICITY WHILE AT HOME. LIAISON WITH THE SPINAL SURGICAL TEAM WAS ONGOING REGARDING INSTALLATION OF A NEW BACLOFEN PUMP, A PROCEDURE THE PATIENT IS KEEN TO UNDERGO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1866286 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

Patients

Seq Age Sex Outcome Treatment
1 48 YR Male Required Intervention| L| H