FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1885018
·
Received October 20, 2010
Report
- Report Number
- 3007566237-2010-08197
- Event Type
- Malfunction
- Date Received
- October 20, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 23, 2010
- 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).
Description of Event or Problem · 1
IT WAS REPORTED AND CONFIRMED BY TELEMETRY THAT DURING SURGERY, UPON THE UPDATE OF THE NEWLY IMPLANTED PUMP, AN AUDIBLE CRITICAL ALARM OCCURRED DUE TO CRITICAL PUMP MEMORY ERROR. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED: |