FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2974391
·
Received February 22, 2013
Report
- Report Number
- 3007566237-2013-00573
- Event Type
- Injury
- Date Received
- February 22, 2013
- Report Date
- January 29, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED THAT THE SKIN AND NOT THE PUMP WAS ERODING. ADJUSTMENTS WERE MADE AND THE PATIENT WAS FINE.
Description of Event or Problem · 1
THE PUMP WAS TOO LARGE FOR THE PATIENT AND IT WAS BREAKING THROUGH HIS SKIN SO THEY PUT IN A SMALLER PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. FOR SUBSEQUENT EVENTS, SEE MANUFACTURER'S REPORT # 3007566237-2013-00572.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78190 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |