FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 3133754
·
Received May 29, 2013
Report
- Report Number
- 6000032-2013-00138
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Report Date
- December 1, 2011
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3550-09, LOT# L97193, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3586, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: LEAD. PRODUCT ID: 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS CONFIRMED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR OR COMPANY REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. SHE HAD AN APPOINTMENT WITH DOCTOR IN (B)(6) 2011.
Description of Event or Problem · 1
THE PATIENT FOUND OUT IN (B)(6) 2011 THAT TWO OF HER "LEADS" WERE BROKEN. THE DEVICE WAS REPROGRAMMED BUT WAS NOT WORKING THAT WAY. SHE DOES NOT WANT SURGERY TO FIX THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234727 | SYNERGY | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT SOFAMOR DANEK PUERTO RICO MFG | 7427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR |