SYNERGY
Report
- Report Number
- 3007566237-2012-02428
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Report Date
- September 11, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 389133, LOT# J0348996V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 389133, LOT# J0348996V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. (B)(6). (B)(4).
(B)(4).
ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PATIENT WAS MISTAKEN REGARDING THE DATE OF HIS DEVICE IMPLANT. THE DEVICE HAD BEEN IMPLANTED APPROXIMATELY THREE YEARS AGO AND THEREFORE THE END OF LIFE (EOL) STATUS OF THE BATTERY WAS CONSIDERED NORMAL BATTERY DEPLETION. THE PATIENT RECEIVED A BATTERY REPLACEMENT ON 2012-(B)(6). THE PATIENT HAD RETURN OF GOOD STIMULATION AND RECOVERED WITHOUT SEQUELAE. THE PATIENT WAS SATISFIED WITH THE THERAPEUTIC EFFECT OF THE NEW BATTERY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS REPORTED THAT END OF LIFE OF THE DEVICE WAS 10 MONTHS, BUT THE LONGEVITY PREDICTION WAS 20 MONTHS AT THE PATIENT'S STIMULATION SETTINGS. THE PATIENT WAS RECEIVING GREAT AND CONSISTENT THERAPY. 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 |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |