FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 3030158
·
Received April 2, 2013
Report
- Report Number
- 6000032-2013-00078
- Event Type
- Injury
- Date Received
- April 2, 2013
- Report Date
- March 12, 2013
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3587A, LOT# LA0067, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 3587A, LOT# LA0067, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS A BROKEN LEAD WHICH WAS CONFIRMED THROUGH X-RAY ON (B)(6) 2005. NO OTHER INFORMATION WAS REPORTED. IT WAS LATER REPORTED THE BROKEN LEAD WAS REPLACED IN 2005.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134795 | SYNERGY | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT SOFAMOR DANEK PUERTO RICO MFG | 7427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |