FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 3071024
·
Received April 22, 2013
Report
- Report Number
- 6000032-2013-00099
- Event Type
- Injury
- Date Received
- April 22, 2013
- Report Date
- April 4, 2013
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: 1997-(B)(6), PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# (B)(4), IMPLANTED: 1997-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3550-09, LOT# L77682, IMPLANTED: 2000-(B)(6), EXPLANTED: 2001-(B)(6), PRODUCT TYPE ACCESSORY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD HER IMPLANT REVISED 10-11 YEARS PRIOR TO REPORT. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172379 | 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 |