FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1865077
·
Received October 6, 2010
Report
- Report Number
- 3007566237-2010-07656
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 13, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER KINKED. THE HEALTH CARE PROFESSIONAL STATED THAT THE KINK "COULD BE DUE TO THE ANCHOR COMING OUT OF PLACE."
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:| CATHETER: MODEL CATHETER, LOT # UNK| IMPLANTED: |