SYNCHROMED II
Report
- Report Number
- 3004209178-2017-16521
- Event Type
- Injury
- Date Received
- August 9, 2017
- Date of Event
- August 7, 2017
- Report Date
- December 15, 2017
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-3043-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NURSE
Narratives
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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 8840 SERIAL# UNKNOWN PRODUCT TYPE PROGRAMMER, PHYSICIAN 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.
THE PUMP WAS RETURNED, AND ANALYSIS FOUND HIGH RESISTANCE IN THE PUMP BATTERY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). THE PATIENT FIRST STARTED EXPERIENCING THE SPASTICITY ON (B)(6) 2017. THE PATIENT'S PUMP BATTERY DEPLETED EARLY, BUT ERI STILL SHOWED 7 MONTHS. THE PUMP WAS NOTED TO BE ALARMING AND TURNED ON "SAFE MODE" DUE TO LOW BATTERY. THEY TRIED CHANGING IT TO SIMPLE CONTINUOUS, HOWEVER WITHIN 5 HOURS THE PUMP WAS BEEPING AGAIN. THE PATIENT WAS SCHEDULED FOR A SURGICAL CONSULT FOR REPLACEMENT.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING 2000 MCG/ML GABLOFEN AT 571.8 MCG/DAY VIA AN IMPLANTABLE PUMP FOR INTRACTABLE SPASTICITY AND CEREBRAL PALSY. IT WAS REPORTED THAT THE PATIENT LIVED IN A CLINICAL SETTING AND THE PROVIDERS HEARD HIS PUMP ALARM. THE EVENT LOGS CONFIRMED A LOW BATTERY RESET AND SAFE STATE OCCURRED ON (B)(6) 2017 AT 1758. THE PUMP WAS REPROGRAMMED BACK TO FLEX MODE AND THE CRITICAL ALARM WAS NOTED TO BE 10 MINUTES. THE PATIENT CURRENTLY HAD NO SYMPTOMS, HOWEVER THE PATIENT WAS RECENTLY HOSPITALIZED FOR NON-PUMP THERAPY RELATED ISSUES (PNEUMONIA AND FUNGAL INFECTION) AND DURING THE HOSPITALIZATION, IT WAS NOTED THAT THE PATIENT'S SPASTICITY WAS WORSE. NO FURTHER COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA THE MANUFACTURERS REPRESENTATIVE INDICATED THAT THE PUMP WAS EXPLANTED ON (B)(6) 2017. THE SERIAL NUMBER OF THE CLINICIAN PROGRAMMER THAT DISPLAYED ERROR CODE 08:08:F9:40-1529(15), INVALID TELEMETRY WAS UNKNOWN. THE EXPLANTED PUMP WAS PLACED IN MAIL BUT THE TRACKING NUMBER WAS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.
THE MANUFACTURERS REPRESENTATIVE INDICATED THAT SHE WAS SENDING THE PUMP BACK FOR ANALYSIS BUT THE PUMP KEPT ALARMING FROM THE LOW BATTERY, RESET, SAFE STATE AND SHE SAW AN (B)(4) INVALID TELEMETRY WHEN INTERROGATING THE AFFECTED PUMP TODAY. TECHNICAL SERVICE SPECIALIST REVIEWED AND TROUBLESHOOTED WITH THE REP AND THE REP WAS THEN ABLE TO SUCCESSFULLY TELEMETRY AND UPDATE THE PUMP. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 560689 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Required Intervention |