FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1936127
·
Received December 13, 2010
Report
- Report Number
- 3007566237-2010-10390
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 28, 2010
- Report Date
- December 3, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S PUMP WAS DISLODGED AND HAD BROKEN FROM THE "STITCHES IN THE ABDOMEN". THE EVENT RESULTED IN THE PT BEING HOSPITALIZED. THE PT HAD SURGERY ON (B)(6) 2010 TO REPOSITION THE PUMP USING A "DACRON SOCK". THE MEDICATION IN THE PT'S PUMP WAS LIORESAL 500.0 MCG/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Hospitalization| R | EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N233889005| IMPLANTED: |