FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 3043540
·
Received April 9, 2013
Report
- Report Number
- 9614453-2013-00587
- Event Type
- Injury
- Date Received
- April 9, 2013
- Date of Event
- March 22, 2013
- Report Date
- March 22, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD RADIOFREQUENCY ABLATION AND THEIR BATTERY SHOWED BEING USED 90-100%. THE PREVIOUS BATTERY MEASUREMENT TAKEN IN (B)(6) 2012 SHOWED LESS THAN 20% USAGE. IT WAS NOTED TECHNICAL SERVICES WAS CONSULTED ON THE SAFETY OF RF ABLATION. THERE WAS NO HARM OR INJURY TO THE PATIENT AND THERE HAVE BEEN NO ACTIONS REQUIRED DUE TO THE EVENT.
Description of Event or Problem · 1
FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GOING FOR A BATTERY REPLACEMENT DUE TO THE LOW BATTERY LEVELS WITH THE CURRENT IMPLANTABLE NEUROSTIMULATOR SYSTEM (INS). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146421 | SYNERGY | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | IPG MFG SWITZERLAND | 7427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |