FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 3040290
·
Received April 8, 2013
Report
- Report Number
- 6000032-2013-00081
- Event Type
- Injury
- Date Received
- April 8, 2013
- Report Date
- March 20, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7435, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: EXTENSION: PRODUCT ID 3487A, LOT# J0228122V, IMPLANTED: (B)(6) 2003. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE PATIENT HAD A NEW LEAD, AS WELL AS A BATTERY REPLACEMENT FOR NORMAL DEPLETION, AND WAS DOING "AWESOME."
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS TO UNDERGO A REVISION. THE PATIENT FELL IN 2009 AND THE LEAD HAS NOT WORKED THE SAME SINCE. THE STIMULATOR MAY ALSO HAVE BEEN REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142659 | 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 |