FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2157809
·
Received June 28, 2011
Report
- Report Number
- 3007566237-2011-04888
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Date of Event
- March 22, 2011
- Report Date
- June 3, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z# 2276-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): FINAL ANALYSIS REPORTED HIGH BATTERY RESISTANCE. PUMP DID NOT RUN FOR 2 MINUTES AT 24,000 UL/DAY AND BENCH TESTING (BCT) LOGS SHOWED A LOW BATTERY RESET (LBR) OCCURRED. THE BATTERY RESISTANCE WAVEFORM TEST SHOWED A HIGH RESISTANCE OF 1656 OHMS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS REPLACED. "NO EVENT" WAS REPORTED.
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 | 57 YR | Required Intervention | CATHETER: MODEL 8709, LOT# L66503| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8575, LOT# J0452923R |