SYNERGY
Report
- Report Number
- 3004209178-2011-05664
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Report Date
- June 27, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
A LOSS OF THERAPEUTIC EFFECT WAS REPORTED. THE NEUROSTIMULATOR HAD BEEN BENEFICIAL TO THE PT FOR 1 TO 2 YEARS POST IMPLANT. A PHYSICIAN INFORMED THE PT THE DEVICE HAD BEEN PUT IN WRONG. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
THE CONSUMER REPORTED THAT THE DEVICE WAS NOT YET REMOVED AND WAS CAUSING HER JERKING AND ANXIETY. THE PATIENT STATED SHE CONTINUES TO FALL AND IS DEPRESSED. THE PATIENT WANTED TO HAVE THE DEVICE REMOVED SHOULD SHE NEED TO HAVE AN MRI IN THE FUTURE. THE PATIENT REPORTED THAT THE DEVICE STOPPED WORKING 1-2 YEARS AFTER IMPLANT. FURTHER INFORMATION FROM THE CONSUMER REPORTED THAT SIX MONTHS AFTER IMPLANT THE DEVICE DIDN'T HELP HER AND SHE WAS JERKING. THE PATIENT SAW HER HEALTHCARE PROVIDER IN 2001 WHO DID A FEW ADJUSTMENTS AND IT DID NOT HELP WITH SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0019914V| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0083589N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0087329N| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT009807P |