FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 2160942
·
Received June 16, 2011
Report
- Report Number
- 3004209178-2011-04481
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 19, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION AND SEIZURES. THE PT'S BROTHER STATED THE LEADS "WERE HOOKED UP BACKWARDS" WHEN THE NEUROSTIMULATOR WAS REPLACED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | PROGRAMMER: MODEL 7435, LOT# NFT065538P| EXTENSION: MODEL 7495-51, LOT# XR0091784N| EXTENSION: MODEL 7495-51, LOT# XR0091786N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0110922V| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3887, LOT# J0110889V |