FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2043591
·
Received March 28, 2011
Report
- Report Number
- 3007566237-2011-02336
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- June 1, 2010
- Report Date
- March 10, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALL LOGS AND TELEMETRY STRIPS WERE REVIEWED AND NO LOW BATTERY RESET, ERI, OR SAFE STATE EVENTS WERE FOUND TO HAVE OCCURRED IN THE FIELD. HOWEVER, A LOW BATTERY RESET OCCURRED IN THE ANALYSIS LAB DURING DECONTAMINATION PROCEDURE. NO FLOW TESTING WAS DONE DUE TO RESET. THE BATTERY RESISTANCE WAVEFORM TEST SHOWED A HIGH RESISTANCE OF 1382 OHMS. THE PRIMARY ANALYSIS FINDING WAS S2 BATTERY RESISTANCE HIGH. BACLOFEN WAS FOUND IN THE PUMP RESERVOIR.
Description of Event or Problem · 1
THE PUMP WAS REMOVED DUE TO BATTERY DEPLETION. THE PATIENT RECOVERED WITHOUT SEQUELA AFTER REMOVAL. A PUMP SAFE STATE AND RESET MESSAGE DISPLAYED WHEN THE PUMP WAS PROGRAMMED FOR MAXIMUM RATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | IMPLANTED:| CATHETER: MODEL 8731, LOT# N003114424| EXPLANTED:| CATHETER: MODEL 8731, LOT# N003435733| EXPLANTED:| IMPLANTED: |