FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1872607
·
Received October 12, 2010
Report
- Report Number
- 3007566237-2010-07864
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 1, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
THE PT WAS HAVING A ROUTINE PUMP REPLACEMENT TO AVOID IN-VIVO BATTERY DEPLETION. HOWEVER, IT WAS REPORTED THAT FOLLOWING A FALL, THE PT'S PUMP WOULD ONLY ACCEPT 14CC OF MEDICATION AT THE PREVIOUS 2 REFILL SESSIONS. THE PT RECOVERED WITHOUT SEQUELA. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS DILAUDID.
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 | 42 YR | CATHETER: MODEL 8709, LOT# N004876321| EXPLANTED:| IMPLANTED: |