PRECISION®
Report
- Report Number
- 3006630150-2011-01414
- Event Type
- Injury
- Date Received
- September 16, 2011
- Date of Event
- August 18, 2011
- Report Date
- August 18, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, AU
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS EXPLANTED AND A NEW IPG WAS IMPLANTED. THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE PROCEDURE. A RETURNED PRODUCT ANALYSIS INDICATED THAT THE COMPLAINT WAS CONFIRMED. THE BATTERY DEPLETION RATE AT THE TIME OF THE ANALYSIS MEASURED ABOVE THE LIMIT, AND THE SLEEP CURRENT MEASURED AT A RATE EXCEEDING THE TYPICAL RANGE. VH TO GROUND MEASURED LOW IMPEDANCE, WHICH IS INDICATION OF DAMAGE TO ANALOG IC. THE DEVICE PROFILE INDICATES THAT THE DEVICE HAS BEEN DEPLETING AT SOME POINT AFTER THE IMPLANT PROCEDURE. THE IPG PASSED ALL OTHER FUNCTIONAL TESTS. THE TIMING OF THE ANOMALY SUGGESTS THAT THE IPG MAY HAVE BEEN EXPOSED TO AN ENVIRONMENT SIMILAR TO THE ELECTROCAUTERY USAGE DURING THE IMPLANT PROCEDURE.
A REPORT WAS RECEIVED THAT THE PATIENT HAS TO CHARGE THEIR IPG MORE FREQUENTLY. BSN REPRESENTATIVE ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. IT HAS BEEN RECOMMENDED THAT THE PATIENT'S IPG BE REPLACED.
A REPORT WAS RECEIVED THAT THE PATIENT HAS TO CHARGE THEIR IPG MORE FREQUENTLY. BSN REPRESENTATIVE ANALYZED THE PATIENT'S DATABASE AND CONFIRMED PREMATURE BATTERY DEPLETION. IT HAS BEEN RECOMMENDED THAT THE PATIENT'S IPG BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |