SYNCHROMED II
Report
- Report Number
- 3004209178-2012-10569
- Event Type
- Injury
- Date Received
- November 20, 2012
- Date of Event
- September 21, 2012
- Report Date
- October 23, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4).
(B)(4).
CATHETER: MODEL UNK, SERIAL# (B)(4), IMPLANTED: UNK, EXPLANTED: UNK. (B)(4).
ADDITIONAL INFORMATION WAS REPORTED THAT THE SUBCUTANEOUS FLUID COLLECTION AROUND THE PUMP AND THE BACK REGION WAS DIAGNOSTICALLY OB SERVED ON (B)(6) 2012. A CEREBROSPINAL FLUID LEAKAGE WAS IDENTIFIED AFTER A CONTRAST EXAMINATION WAS PERFORMED AND NO ABNORMALITY WAS DETECTED WITH THE PUMP SYSTEM. OVER THE COURSE OF SEVERAL DAYS THE SWELLING DISSIPATED AND ON (B)(6) 2012 AS A RESULT THE SYMPTOMS WERE DETERMINED AS HAD BEEN RESOLVED. ON (B)(6) AS MUSCLE TENSION DEMONSTRATED LITTLE IMPROVEMENT A CATHETER CONTRAST EXAMINATION WAS PERFORMED ONCE AGAIN, FOLLOWED BY CT IMAGING. AN UNEVEN DISTRIBUTION OF CONTRAST AGENT. ON (B)(6) 2012, THIS SUSPICION DULY RESULTED IN RESURGERY(A LAMINECTOMY AND THE READJUSTMENT OF THE CATHETER TIP¿S POSITION) BEING PERFORMED. NO OBVIOUS ABNORMALITY WAS OBSERVED IN THE INTRAOPERATIVE FINDINGS. ON (B)(6) 2012, DAILY DOSE 400 TO 100, BECAUSE MUSCLE TENSION WAS TOO PROFOUND TO ENABLE REMOVAL OF THE TUBING, THE DAILY DOSE WAS SUBSEQUENTLY REDUCED TO 400 UG/DAY. ALTHOUGH THE TUBING COULD SUCCESSFULLY BE REMOVED, A DECREASED IN THE RESPIRATORY RATE WAS OBSERVED; HENCE THE DAILY DOSE WAS TEMPORARILY REDUCED TO 100 UG/DAY. WHEREUPON THE RESPIRATORY RATE REVERTED TO NORMAL LEVELS. THE PHYSICIAN¿S ASSESSMENT: THERE WAS A CONSPICUOUS DISPARITY IN THE PATIENT¿S SYMPTOMS DURING THOSE TIMES WHEN MUSCLE TENSION WAS RELIEVED AND DURING THOSE WHEN IT PERSISTED AND THE REASON BEHIND THIS DISPARITY WAS AS YET UNCLEAR. STILL THE BACLOFEN INTRATHECAL MIGHT POSSIBLY BE PROVING EFFECTIVE AND CLOSE SCRUTINY WILL CONTINUE TO BE PAID. SUBSEQUENT TO (B)(6): FROM THE CT IMAGING FOLLOWING THE CONTRAST EXAMINATION, A CATHETER PROBLEM WAS SUSPECTED, ALTHOUGH NO OBVIOUS ABNORMALITY WAS OBSERVED FROM THE FINDINGS OF THE RE-SURGERY. TO ENABLE THE PATIENT TO COPE WITH THE POST-OPERATIVE MUSCLE TENSION, CERTAIN MEASURES WERE UNDERTAKEN SUCH AS ADJUSTING THE BACLOFEN DOSAGE AND AUGMENTING INTERNAL MEDICINES (TIZANIDINE AND DIAZEPAM). ORAL MEDICINES SEEMED TO PROVE SLIGHTLY MORE EFFECTIVE THAN BACLOFEN. THE HEALTH CARE PROVIDER INDICATED THAT THE EVENT WAS NOT RELATED TO THE PUMP AND CATHETER; INSTEAD, IT POSSIBLY HAD BEEN CAUSED BY BACLOFEN¿S REDUCED EFFECTIVENESS VIS-À-VIS THE PATIENT¿S UNDERLYING DISEASE. THE PHYSICIAN STATED ¿INCREASING THE DOSAGE RATE FROM 200 UG TO 400 UG MIGHT INTERACT WITH ADMINISTRATION OF ADDITIONAL ANALGESICS RESULTING IN EXCESSIVE RELIEF OF MYOTONE.¿ THE PHYSICIAN DECIDED TO ATTEMPT A LOW CONCENTRATION BOLUS INJECTION AND IMPLEMENTED A BRIDGE BOLUS AND PROGRAMMING IN FLEX MODE. THE CONCENTRATION WAS CHANGED FROM 2000 UG/ML TO 250 UG/ML AT 11:00 ON (B)(6) 2012. AND AT 14:00 A BOLUS OF 100 UG WAS OBSERVED. EFFICACY WAS OBSERVED HOWEVER THE PATIENT¿S RESPIRATORY RATE DECREASED TO 7 AROUND 19:00. THE PATIENT WAS TRANSFERRED TO THE ICU AND THE DOSE WAS REDUCED TO A MINIMUM. AROUND 23:00 THE PATIENT AWOKE AND STARTED TO RECOVER. ON (B)(6) 2012, A BOLUS INJECTION WAS PERFORMED AND AN APPROXIMATELY 20 UG/ML OF BACLOFEN WAS EFFECTIVE. THE PATIENT DEVELOPED BRADYPNEA AND REQUIRING ASSISTED RESPIRATION WITH BIPAP IN ICU. THE PATIENT¿S CIRCULATION WAS STABLE AND THE SYMPTOM IMPROVED NEXT MORNING BY DISCONTINUING DOSING OF BACLOFEN.
IT WAS LATER REPORTED THAT THE PATIENT WAS ASSESSED ON (B)(6) 2013 AND WAS NOTED TO BE ¿IMPROVED¿ AND THE THERAPY WAS "EFFECTIVE".
IT WAS INITIALLY REPORTED ON (B)(6) 2012 THAT A PHYSICIAN CONFIRMED INCREMENT OF MUSCULUS TONUS TO THE PATIENT WHICH OCCURRED ON (B)(6) 2012. THE PATIENT VISITED A HOSPITAL ON (B)(6) 2012 AND BOTH A CONTRAST RADIOGRAPHY OF THE CATHETER AND PUMP ROTOR TEST REVEALED NO ANOMALY. ON (B)(6) 2012, THE PATIENT RECOVERED FROM THE MUSCULUS TONUS AND LEFT THE HOSPITAL. A CT TEST OF THE CATHETER WAS PERFORMED ON (B)(6) 2012 AND NO ANOMALY WAS FOUND. A PHYSICIAN COMMENTED IT WAS A RELIEF TO KNOW THAT THERE WERE NO PROBLEMS WITH THE PATIENT'S DEVICES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 FROM A HCP INDICATED THAT THE PATIENT EXPERIENCED WORSENING OF MYOTONIA AND INCREASED MUSCLE TENSION; WITH AN ONSET OF (B)(6) 2012. THE EVENT REQUIRED HOSPITALIZATION / PROLONGED HOSPITALIZATION. THE WORSENING MYOTONIA WAS UNRELATED TO THE PATIENT'S DEVICE SYSTEM AND DRUG. THE FOLLOWING TESTS/STUDIES WERE PERFORMED, HOWEVER, REVEALED NO ISSUES: PUMP OPERABILITY TEST, ROTOR TEST, AND X-RAY OF THE CATHETER. HCP NOTED THAT THE PATIENT WAS DISCHARGED ACCORDINGLY ON (B)(6) 2012, AS THE PATIENT'S MUSCLE TENSION WAS RELIEVED FOLLOWING EXAMINATIONS (CONTRAST STUDY AND ROTOR TEST). FOR TWO DAYS THE PATIENT'S CONDITION WAS SATISFACTORY, BUT THEN THE MUSCLE TENSION INCREASED ONCE AGAIN AND THE PATIENT RETURNED TO THE HOSPITAL. ANOTHER CT EXAMINATION SHOWED NO SYSTEMIC ABNORMALITY. AS THE EVENT MAY HAVE BEEN TRIGGERED BY AN INSUFFICIENT DOSAGE, PHYSICIANS WERE CONSIDERING INCREASING THE DOSAGE AND ALSO ALTERING THE CATHETER POSITION; ALTHOUGH NOTHING ABNORMAL WAS DETECTED FROM EXAMINATION. ON (B)(6) 2012 A CONTRAST EXAMINATION WAS PERFORMED, IMMEDIATELY FOLLOWED BY A CT IMAGING EXAMINATION, AND NO ABNORMALITY WAS IDENTIFIED. A PHYSICIAN NOTED THAT NO PUMP SYSTEM PROBLEM HAD BEEN DETECTED FROM THE EXAMINATIONS; HOWEVER, "THERE IS A CONSPICUOUS DISPARITY IN THE PATIENT'S SYMPTOMS DURING THOSE TIMES WHEN MUSCLE TENSION IS RELIEVED AND DURING THOSE WHEN IT PERSISTS, AND THE REASON BEHIND THIS DISPARITY IS NOT YET UNCLEAR". THE PHYSICIAN FURTHER INDICATED THAT THE BACLOFEN INTRATHECAL THERAPY WAS POSSIBLY PROVING EFFECTIVE AND CLOSE SCRUTINY WILL CONTINUE TO BE PAID. A CT IMAGING EXAMINATION WAS PERFORMED AGAIN ON (B)(6) 2012 AS THE PATIENT'S MUSCLE TENSION WAS NOT RELIEVED. IT WAS NOTED THAT ALTHOUGH DRUG DISTRIBUTION WAS APPARENT, SEVERAL SITES WERE EVIDENTLY SUBJECT TO POOLING NEVERTHELESS. THE POOLING WAS NOTED AS NOT HAVING BEEN IDENTIFIED AS THE CAUSE OF THE PATIENT'S SYMPTOMS. A PHYSICIAN PLANNED TO INCREASE THE FLOW RATE BY REDUCING THE DRUG CONCENTRATION. ALTERING THE CATHETER POSITION WAS FURTHER BEING CONSIDERED. AS OF (B)(6) 2012, A PHYSICIAN FURTHER EXAMINED THE CT IMAGES AND ADJUDGED THAT THE PATIENT'S CONDITION WAS A RESULT OF VESICULATION. A LAMINECTOMY WAS THEREFORE PERFORMED TO FACILITATE REMOVAL. VESICULATION COULD NOT BE CONFIRMED VISUALLY. THE AREA SURROUNDING THE CATHETER TIP WAS CLEANSED. THE PHYSICIAN FURTHER NOTED THAT SHOULD THE CLEANSING NOT PROMOTE EFFECT, THEN THERE MIGHT BE ANOTHER CAUSE FOR THE PATIENT'S ISSUE. THE DAILY DOSE RATE OF BACLOFEN WAS ADJUSTED TO 200 MCG/DAY. FOR THE TREATMENT OF SPASMS, THE PATIENT RECEIVED THE FOLLOWING: PHENOBAL (POWDER , 70 MG, ORAL), TERNELIN (GRANULES, 3 MG, ORAL), GABALON (TABLETS, 3 MG, ORAL), ARTANE (POWDER, 4.5 MG, ORAL), CERCINE (POWDER, 1 MG, ORAL), TRICLORYL (SYRUP, 5 MG, ORAL). FOR THE TREATMENT OF "COMPLICATIONS" THE PATIENT RECEIVED THE FOLLOWING: RIVOTRIL (FINE GRANULE, 0.7 MG, ORAL), HYSERENIN (FINE GRANULE, 300 MG, ORAL), EXCEGRAN (POWDER, 130 MG, ORAL).
ADDITIONAL/CORRECTED INFORMATION: [PLEASE REFER TO MFR REPORT 3004209178-2012-09107 FOR THIS EVENT THAT WAS REPORTED IN ERROR IN THE SECOND FOLLOW-UP REPORT: THE SUBCUTANEOUS FLUID COLLECTION AROUND THE PUMP AND THE BACK REGION WAS DIAGNOSTICALLY OBSERVED ON (B)(6) 2012. A CEREBROSPINAL FLUID LEAKAGE WAS IDENTIFIED AFTER A CONTRAST EXAMINATION WAS PERFORMED AND NO ABNORMALITY WAS DETECTED WITH THE PUMP SYSTEM. OVER THE COURSE OF SEVERAL DAYS THE SWELLING DISSIPATED AND ON (B)(6) 2012 AS A RESULT THE SYMPTOMS WERE DETERMINED AS HAD BEEN RESOLVED.] ON (B)(6) 2012, IT WAS ADDITIONALLY STATED THAT THE PATIENT'S DECREASED RESPIRATORY RATE WAS NOT CAUSED BY DRUG OVERDOSE (THE PUMP DRUG DOSE WAS INCREASED FROM 200 MCG/DAY TO 400 MCG/DAY ON (B)(6) 2012). ON (B)(6) 2012, AS MUSCLE TENSION DEMONSTRATED LITTLE IMPROVEMENT, A CATHETER CONTRAST EXAMINATION WAS PERFORMED ONCE AGAIN, FOLLOWED BY CT IMAGING. AN UNEVEN DISTRIBUTION OF CONTRAST AGENT WAS OBSERVED AND A FAST FLOW OR FOLLICULAR FORMATION AT THE CATHETER TIP WAS SUSPECTED. THEREFORE, A LAMINECTOMY AND READJUSTMENT OF THE CATHETER TIP POSITION WERE SURGICALLY PERFORMED. NO OBVIOUS ABNORMALITY WAS OBSERVED INTRAOPERATIVELY. THE SUSPECTED FOLLICULAR FORMATION WAS NOT CONSIDERED AN ADVERSE EVENT. ON (B)(6) 2013, WHEN PATIENT WAS TRANSFERRED TO AN INTENSIVE CARE UNIT, AND THE DOSE WAS REDUCED TO A MINIMUM RATE AND AROUND 23:00, THE PATIENT AWOKE AND STARTED TO RECOVER, IT WAS STATED THAT THE DECREASED RESPIRATORY RATE WAS CONSIDERED TO BE RELATED TO DRUG, BUT UNRELATED TO THE DEVICE SYSTEM OR PROCEDURE. THE PHYSICIAN INDICATED THEY DID NOT EXPECT SUCH A REMARKABLE EFFECT CAN BE ACHIEVED BY LOW-CONCENTRATION BOLUS INJECTION. ALTHOUGH DOSE ADJUSTMENT WAS ¿DIFFICULT¿, THEY WERE PLEASED WITH THE EFFECTIVENESS. THIS CASE WAS CONSIDERED TO BE ¿OBVIOUSLY AN OVERDOSING.¿ THE SEVERE DECREASED RESPIRATORY RATE WAS NOTED AS DEFINITELY BEING DUE TO DRUG IN REGARDS TO AN OVERDOSE. THE PATIENT'S CIRCULATION WAS STABLE, AND THEIR SYMPTOMS IMPROVED THE NEXT MORNING AFTER DISCONTINUING DOSING OF BACLOFEN. THE PATIENT WAS ASSESSED AGAIN AND WAS NOTED AS HAVING RECOVERED AS OF (B)(6) 2012. LATER, THE PATIENT AGAIN EXPERIENCED A MILD DECREASED RESPIRATORY RATE WITH AN ONSET OF (B)(6) 2012. AN OVERDOSE WAS AGAIN INDICATED. ON THE THIRD DAY, AFTER CHANGING TO A NEW FLEX DOSING SETTING, BOTH BRADYCARDIA AND REDUCED RESPIRATORY RATE WERE OBSERVED. THE PATIENT HAD A HEART RATE OF 50 AND THE RESPIRATORY RATE 10/MIN. THE PATIENT'S BLOOD PRESSURE WAS STABLE. THE CONTINUOUS BACLOFEN INTRATHECAL INJECTION WAS TEMPORARILY SET TO THE MINIMAL RATE, AND SUBSEQUENTLY THE PATIENT'S SYMPTOMS RECOVERED TO NORMAL WITHIN THAT SAME DAY ((B)(6) 2012). CAUSALITY WAS BELIEVED TO BE PROBABLY DUE TO DRUG, BUT NOT RELATED TO THE DEVICE SYSTEM OR PROCEDURE. THE SEVERE DECREASED RESPIRATORY RATE WAS NOTED AS DEFINITELY BEING DUE TO DRUG IN REGARDS TO AN OVERDOSE. THE PATIENT'S CIRCULATION WAS STABLE, AND THEIR SYMPTOMS IMPROVED THE NEXT MORNING AFTER DISCONTINUING DOSING OF BACLOFEN. THE PATIENT WAS ASSESSED AGAIN AND WAS NOTED AS HAVING RECOVERED AS OF (B)(6) 2012. LATER, THE PATIENT AGAIN EXPERIENCED A MILD DECREASED RESPIRATORY RATE WITH AN ONSET OF (B)(6) 2012. AN OVERDOSE WAS AGAIN INDICATED. ON THE THIRD DAY, AFTER CHANGING TO A NEW FLEX DOSING SETTING, BOTH BRADYCARDIA AND REDUCED RESPIRATORY RATE WERE OBSERVED. THE PATIENT HAD A HEART RATE OF 50 AND THE RESPIRATORY RATE 10/MIN. THE PATIENT'S BLOOD PRESSURE WAS STABLE. THE CONTINUOUS BACLOFEN INTRATHECAL INJECTION WAS TEMPORARILY SET TO THE MINIMAL RATE, AND SUBSEQUENTLY THE PATIENT'S SYMPTOMS RECOVERED TO NORMAL WITHIN THAT SAME DAY ((B)(6) 2012). CAUSALITY WAS BELIEVED TO BE PROBABLY DUE TO DRUG, BUT NOT RELATED TO THE DEVICE SYSTEM OR PROCEDURE. ON (B)(6) 2013, IT WAS STATED THAT THE PATIENT'S REDUCED RESPIRATORY RATE EXPERIENCED ON (B)(6) 2012, THE RATE WAS REPORTED TO BE 6-8 RESPIRATIONS PER MINUTE. AS A RESULT, THE MEDICATIONS DIAZEPAM AND TIZANIDINE WERE TEMPORARILY REDUCED. AS THINGS STAND, NO PUMP SYSTEM PROBLEM HAS BEEN DETECTED FROM THE EXAMINATIONS. IT WAS NOW NOTED THAT THE PHYSICIAN DID NOT CONSIDER THE BACLOFEN DOSE OF 400 UGDAY AS AN OVERDOSE, IF THE PATIENT WAS TAKING NO OTHER MEDICATION. THE PATIENT'S NORMAL RESPIRATORY RATE DURING SLEEP IS AROUND 30 (PER MINUTE). [THIS EVENT MAY ALSO BE REFERRED TO IN A SUBMITTED MFR REPORT # (B)(4)] AS OF (B)(6) 2013 ADDITIONAL INFORMATION INDICATED THAT MULTIPLE GABALON DOSE ADJUSTMENTS FOR SPASM CONTROL WERE PERFORMED FROM (B)(6) 2012; THE DOSE WAS INCREASED FORM 200 MCG/DAY TO 400 MCG/DAY. THE GABALON DOSE WAS DECREASED TO 100 MCG/DAY ON (B)(6) 2012 REGARDING SPASM CONTROL. MULTIPLE GABALON DOSE ADJUSTMENTS FOR SPASMS CONTROL WERE ALSO PERFORMED FROM (B)(6) 2012, IN WHICH THE DOSE WAS INCREASED FROM 200 MCG/DAY TO 400 MCG/DAY (SIMPLE CONTINUOUS RATE). ON (B)(6) 2012, THE PATIENT'S PUMP DOSE WAS CHANGED FROM BEING A SIMPLE CONTINUOUS RATE TO A FLEX DOSE RATE FOR SPASM CONTROL. FOLLOWING THE FIRST BOLUS INJECTION ON (B)(6) 2012, AND AFTER CHANGING THE INJECTION MODE, OBVIOUS MUSCLE TENSION WAS OBSERVED AROUND 14:30. THE PUMP DOSE WAS REDUCED TO 12 MCG/DAY (MINIMUM RATE) ON (B)(6) 2012 AND SET TO SIMPLE CONTINUOUS. MULTIPLE GABALON DOSE ADJUSTMENTS (FLEX DOSING) FOR SPASM CONTROL WERE LATER MADE FROM (B)(6) 2012 TO (B)(6) 2013; THE DOSE RATE RANGED FROM 160 MCG/DAY TO 230 MCG/DAY. THE PATIENT WAS ASSESSED ON (B)(6) 2013 (6 MONTHS POSTOPERATIVE OF PUMP IMPLANT) AND NO CHANGE OCCURRED REGARDING IMPROVEMENT IN SPASTICITY AND ACTIVITIES OF DAILY LIVING (ADL) FUNCTION VS. PRE-DOSING. THE PATIENT HOWEVER IMPROVED AT 12 MONTHS POSTOPERATIVE. ALTHOUGH THE RATING SHOWED SLIGHTLY Y WORSENED VALUES, THE PATIENT'SCONDITION WAS ASSESSED AS IMPROVED. IT WAS ALSO REPORTED THAT THE PATIENT BEGAN TO RECEIVE RISPERDAL (0.1 MG/DAY) ORALLY FROM (B)(6) 2012 AND CONTINUING FOR TREATMENT OF SPASMS. THE FLEX DOSE RATE VIA THE PUMP LATER REMAINED UNCHANGED FROM (B)(6) 2013. ON (B)(6) 2013, THE PATIENT BEGAN TAKING E KEPPRA (400 MG/DAY) ORALLY REGARDING ¿COMPLICATIONS¿; ADMINISTRATION OF E KEPPRA WAS CONTINUING FROM (B)(6) 2013. REGARDING ¿COMPLICATIONS¿; ADMINISTRATION OF (B)(6) 2013 WAS NOTED.
IT WAS FURTHER REPORTED THAT OVERDOSE ADMINISTRATION SYMPTOM OF WITHDRAWAL PUMP OPERATION TEST FOR DRUG TOLERANCE EPISODE CATHETER TEST (B)(6) 2012.THE SETTINGS OF FLEX ADMINISTRATION WAS CHANGED ON (B)(6) 2012. IT WAS FURTHER REPORTED THAT THE PATIENT'SFINAL CHECK WAS ON (B)(6) 2013. THE OVERALL ASSESSMENT OF LONG-TERM CONTINUOUS ADMINISTRATION WAS NOTED AS EFFECTIVE AND TO BE IMPROVED AT 12 MONTHS POSTOPERATIVE. THE PATIENT PRESENTED NO CHANGES FROM THE ASHWORTH SCALE RATED AS EVALUATING THE MAXIMUM TENSION IN.ALTHOUGH THE RATING SHOWS SLIGHTLY WORSENED VALUES, THE PATIENT'S CONDITION WAS ASSESSED AS IMPROVED BECAUSE BOTH THE DURATION OF TENSION THROUGHOUT THE DAY AND HAVE INCREASED. A RATIONALE FOR OVERDOSE ON (B)(6) 2012 WAS THE FOLLOWING: THE INJECTION MODE WAS CHANGED ON THE DAY SO THAT THE PATIENT RECEIVES A 100 UGBOLUS AT 6:00, 14:00 AND 22:00 (3 TIMES A DAY) AND THE REMAINING 100 UGOVER 24 HOURS; AROUND 14:30 (FOLLOWING THE FIRST BOLUS INJECTION AFTER CHANGING THE INJECTION MODE), OBVIOUS MUSCLE TENSION WAS OBSERVED. THIS WAS A CLINICAL AND NO OTHER EXAMS WERE PERFORMED. FURTHER ON (B)(6) 2012, FLEX ADMINISTRATION SETTINGS WERE CHANGED ON (B)(6) 2012. (UP UNTIL THEN, THEY WERE XXXXX. AFTERWARDS, X XWAS ADMINISTERED AT 2:00 A.M., 6:00 A.M., 10:00 A.M., 2:00 P.M., 6:00 P.M., AND 10:00 P.M. AT 30 UG EACH TIME. OVERALL, XXXX WAS ADMINISTERED. THREE DAYS LATER, A BRADYCARDIA AND REDUCED RESPIRATORY RATE WERE X. A CAUSAL RELATIONSHIP BETWEEN TEMPORAL MODE CHANGES AND THE MANIFESTATION OF SYMPTOMS WAS SUSPECTED; XX WAS IMPROVED DUE TO X IN THE SINGLE MODE, SO ANY EXAMINATIONS BEYOND THAT WERE NOT CONDUCTED. THE PATIENT'S ADVERSE EVENT OF DECREASED RESPIRATORY RATE WHICH OCCURRED ON (B)(6) 2012 WAS REPORTED AS RESOLVED AS OF (B)(6) 2012 WITH THE INVESTIGATIONAL DRUG DOSE CHANGED. THIS REPORTED AS POSSIBLY RELATED TO THE INVESTIGATIONAL DRUG. THE DECREASED IN RESPIRATORY RATE ON (B)(6) 2012 WAS REPORTED AS RECOVERED AS OF (B)(6) 2012 WITH THE INVESTIGATIONAL DRUG ADMINISTRATION BEING SUSPENDED AND DEFINITELY BEING RELATED TO THE INVESTIGATIONAL DRUG. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00045 MO | Hospitalization| R |