SYNCHROMED II
Report
- Report Number
- 3004209178-2017-13064
- Event Type
- Injury
- Date Received
- June 16, 2017
- Date of Event
- June 9, 2017
- Report Date
- August 15, 2017
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- UDI-DI
- 00643169100824
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-0497-2013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS OF THE PUMP REVEALED PUMP MOTOR AND GEAR TRAIN ANOMALIES RELATED TO CORROSION AND/OR WEAR AND/OR LUBRICATION, AND STALL DUE TO SHAFT-BEARING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ON 2017-JUL-10, ADDITIONAL INFORMATION WAS RECEIVED WHICH CLARIFIED THE PATIENT'S INTRACTABLE SPASTICITY AS OF CEREBRAL ORIGIN. MEDICAL HISTORY INCLUDED CEREBRAL PALSY, EPILEPSY WITH SEIZURES, REACTIVE AIRWAY DISEASE, BEING WHEELCHAIR BOUND, BEING LEGALLY BLIND, SLEEP APNEA (USES CPAP [CONTINUOUS POSITIVE AIRWAY PRESSURE]); A SPINAL FUSION (WITH RODS AT 11 YEARS) ON (B)(6) 200; A GASTROSTOMY TUBE; USE OF CODEINE WITH GASTRIC BLEEDING; USE OF SULFA DRUGS WITH SEVERE HIVES; SCOLIOSIS; SCOLIOSIS RODS REVISION (AT 17 YEARS); AND A NISSEN FUNDOPLICATION (AT 4 YEARS). CONCOMITANT PRODUCTS INCLUDED ALBUTEROL 2.5 MG, 4X/DAY; PULMICORT (BUDESONIDE)0.5 MG, 2X/DAY; VIMPAT (LACOSAMIDE) 150 MG, 2X/DAY BY G-TUBE; KEPPRA (LEVETIRACETAM) 1250 MG ORALLY 1X/DAY IN AM, 1750 MG ORALLY 1X/DAY IN PM; MONTELUKAST 10 MG, 1X/DAY BY G-TUBE; GABITRIL (TIAGABINE HYDROCHLORIDE) 4 MG TWICE DAILY ORALLY, TYLENOL (ACETAMINOPHEN) 650 MG EVERY 4 HOURS AS NEEDED FOR PAIN; AND FLEXERIL (CYCLOBENZAPRINE HYDROCHLORIDE) 10 MG 3X/DAY AS NEEDED FOR MUSCLE SPASM. ON (B)(6) 2017, THE PATIENT PRESENTED TO THE HOSPITAL WITH THE CHIEF COMPLAINT OF A BACLOFEN PUMP CRITICAL ALARM. THE PATIENT'S MOTHER REPORTED THAT WHEN SHE ARRIVED HOME FROM WORK THAT DAY SHE HEARD THE PATIENT'S ALARM GOING OFF AND THE PATIENT HAD EXPERIENCED 6 SEIZURES IN APPROXIMATELY 4 HOURS. SHE HAD CALLED THE PATIENT'S NEUROSURGEON AND WAS TOLD TO BRING THE PATIENT TO THE EMERGENCY ROOM (ER). THE COURSE/DURATION OF THE PATIENT'S SYMPTOMS WAS CONSIDERED CONSTANT AND THE DEGREE WAS CONSIDERED MODERATE. ON (B)(6) 2017, THE PATIENT'S BLOOD PRESSURE WAS ELEVATED WITH A READING OF 198/129 MMHG. ON (B)(6) 2017, AN ECG (ELECTROCARDIOGRAM) WAS PERFORMED AND REVEALED SINUS TACHYCARDIA, BUT WAS OTHERWISE A NORMAL ECG. ON (B)(6) 2017 AT 23:04, THE PATIENT WAS ADMITTED TO AN INPATIENT HOSPITAL UNIT. THE TREATMENT PLAN INCLUDED CONTINUOUS MONITORING OF THE PATIENT AS THE PATIENT WAS AT RISK FOR WITHDRAWAL DUE TO ABRUPT CESSATION OF BACLOFEN AND A NEUROLOGY CONSULT TO MANAGE ORAL BACLOFEN REPLACEMENT TO PREVENT WITHDRAWAL AND SEIZURE MANAGEMENT. THE PATIENT'S PUMP WAS INTERROGATED WHICH CONFIRMED SERIAL PUMP MOTOR STALLS AND A PUMP REMOVAL AND REPLACEMENT WAS RECOMMENDED. ON (B)(6) 2017, A CHEST X-RAY WAS PERFORMED AND REVEALED NO ACUTE CARDIOPULMONARY ABNORMALITY. THE PATIENT RECEIVED THE DIAGNOSES OF SEIZURE AND BACLOFEN PUMP FAILURE. ON (B)(6) 2017, THE PATIENT'S PUMP WAS EXPLANTED AND REPLACED (WITH A SYNCHROMED MODEL 8637-40) FOR THE PRE AND POST-OPERATIVE DIAGNOSES OF SPASTICITY OF CEREBRAL ORIGIN. THE NEW PUMP WAS FILLED WITH BACLOFEN 2000 ¿G/ML, THEN PRIMED AND ATTACHED TO THE PATIENT'S EXISTING CATHETER. THE PATIENT'S DOSING WAS RESUMED AT THE PRE-OPERATIVE SETTINGS. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY COMPLICATIONS AND WAS SENT TO THE PACU (POST ANESTHESIA CARE UNIT). THE EXPLANTED PUMP WAS RETURNED TO THE MANUFACTURER. AS OF (B)(6) 2017, THE RESOLUTION OF THE REPORTED EVENTS WAS NOT REPORTED. ON (B)(6) 2017, THE PATIENT'S WEIGHT AT THE TIME OF THE EVENTS WAS NOTED TO BE (B)(6) KG. ON 2017-JUL-20, ADDITIONAL INFORMATION REGARDING THE PATIENT¿S CONCOMITANT PRODUCTS INCLUDED THAT THE PATIENT USED PULMICORT RESPULES 0.5 MG VIA NEBULIZATION 2X/DAY. IT WAS LEARNED THAT THE PUMP WAS INTERROGATED BY THE MANUFACTURER AND IT WAS FOUND TO BE INTERMITTENTLY FREEZING FOR HOURS AT A TIME. THE BEEPING/ALERT STOPPED ON (B)(6) 2017 NIGHT AND THEN REOCCURRED ON (B)(6) 2017 NIGHT. URINE CULTURE ON (B)(6) 2017, INDICATED NO GROWTH AND THE URINE BETA HUMAN CHORIONIC GONADOTROPIN (HCG) TEST ON (B)(6) 2017 WAS NEGATIVE. ON (B)(6) 2017, THE PATIENT WAS DOING WELL AND THE BP HAD DROPPED TO 132/97. THE PATIENT¿S DIAGNOSIS LIST INCLUDED A BACLOFEN PUMP FAILURE AND SEIZURES. ON (B)(6) 2017, THE PATIENT UNDERWENT GENERAL ANESTHESIA AND HER PREVIOUS LEFT-SUBCOSTAL INCISION WAS REOPENED. THE PUMP WAS DISCONNECTED FROM THE CATHETER AND THE CATHETER WAS CLAMPED AND THE PUMP WAS ASPIRATED UNTIL IT WAS EMPTY. THE NEW PUMP WAS FILLED WITH BACLOFEN 2000 G/ML, PRIMED, AND IMPLANTED. THE DOSING WAS RESUMED AT THE SAME SETTINGS AS THE PREOPERATIVE SETTINGS. THE INCISION WAS COPIOUSLY IRRIGATED WITH ANTIBIOTIC IRRIGATED AND OPERATIVE SITE WAS CLOSED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE PACUE POSTOPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED OR EXPECTED.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A CONSUMER RECEIVING BACLOFEN [2 000 MCG/ML] AT A RATE OF 1,702 MCG/DAY VIA INTRATHECAL DRUG DELIVERY PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THERE WAS A MOTOR STALL SEEN AT INITIAL INTERROGATION. THE PATIENT DID NOT RECENTLY HAVE AN MRI AND THERE WERE SEVERAL MOTOR STALLS IN THE LAST 48 HOURS. PER THE EVENT LOGS ON (B)(6) 2017 WAS THE FIRST STALL AND THEN 3 OTHER STALLS ON (B)(6) 2017. THE STALL RECOVERIES WOULD OCCUR 3 HOURS LATER AND THEN HOURS AND HOURS LATER THE PUMP STALLED AGAIN. THERE WAS NO STALL RECOVERY SINCE 2 HOURS AGO ON (B)(6) 2017 WHEN THE PUMP STATUS WAS CHECKED AND THE PATIENT WAS EXPERIENCING WITHDRAWAL FROM THE INTRATHECAL DRUG AND THE PUMP CRITICAL ALARM WAS HEARD (B)(6) 2017 NIGHT BY THE PATIENT'S PARENTS AND WAS HEARD AGAIN THE NEXT MORNING. IT WAS STATED THAT THE PATIENT DID NOT SPEAK. THE PARENTS NOTICED THE PATIENT WAS EXPERIENCING RIGIDITY AND SWEATING OVER THE WEEKEND (AS OF (B)(6) 2017), WHICH IS NORMAL FOR THE PATIENT WHEN EXERCISING AS THAT INCREASED THE PATIENT'S SPASTICITY (AFTER P.T./INCREASED SPASTICITY), THE PATIENT RELAXED AND IT GOT BETTER/BACK TO NORMAL BUT THIS WAS DIFFERENT BECAUSE THERE WAS NO EXERCISE CAUSING THE SYMPTOMS AND THAT'S WHEN THE PATIENT'S PARENTS KNEW THERE WAS AN ISSUE. ON MONDAY MORNING ((B)(6) 2017) THEY WERE PUT ON ORAL BACLOFEN AND THERE HAD BEEN NO RECENT PUMP REFILLS OR MRIS. THE PATIENT WAS HAVING AN EMERGENCY REPLACEMENT ON (B)(6) 2017 AND THOUGHT THERE WAS LIORESAL IN THE EXISTING PUMP, BUT WAS NOT CERTAIN OF THAT AND WOULD SEND BACK THE AFFECTED PUMP AND EVENT LOGS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017 FROM THE MANUFACTURER REPRESENTATIVE. IT WAS STATED THAT THE PATIENT WAS DOING WELL WITH HER REPLACEMENT. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP WITH THE HCP ON (B)(6) 2017. THE REPRESENTATIVE WOULD REPORT ANY CHANGES AT THE TIME OF THE APPOINTMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) ON 2017-JUN-18. THE PUMP PRINT OUT INDICATED THAT T HERE WERE MOTOR STALLS AT 02:55 ON (B)(6) 2017 AND RECOVERED AT 05:08 OF THE SAME DAY, AT 11:24 ON (B)(6) 2017 AND RECOVERED AT 11:29 OF THE SAME DAY, AT 15:05 ON (B)(6) 2017 AND RECOVERED AT 19:32 OF THE SAME DAY, AND AT 18:24 ON (B)(6) 2017 AND RECOVERED AT 22:43 OF THE SAME DAY. THE PUMP WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429208 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 | 00643169100824 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Hospitalization| R |