FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 2130515
·
Received June 14, 2011
Report
- Report Number
- 3004209178-2011-04404
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- January 1, 2008
- Report Date
- May 17, 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
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT REPORTED THAT HER IMPLANTABLE NEUROSTIMULATOR (INS) MALFUNCTIONED AND WAS EXPLANTED IN 2008. THE INS WAS SOMEWHAT HELPING TO MANAGE HER PAIN. ADD'L HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L 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 | 51 YR | Required Intervention | LEAD: MODEL 3998, LOT# LA4555| IMPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK014276V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT042241P| EXTENSION: MODEL 7495LZ, LOT# NHK014275V| EXPLANTED: |