FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 2972016
·
Received February 21, 2013
Report
- Report Number
- 3004209178-2013-02941
- Event Type
- Injury
- Date Received
- February 21, 2013
- Report Date
- February 1, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID, 748951 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7435 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3998 LOT# V006888, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT'S LAST DEVICE HAD EARLY BATTERY DEPLETION. THE PATIENT'S DEVICE WAS EXPLANTED APPROXIMATELY SEVEN MONTHS AFTER THE IMPLANTATION DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76926 | SYNERGY | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO | 7427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |