PRECISION®
Report
- Report Number
- 3006630150-2011-00656
- Event Type
- Injury
- Date Received
- May 6, 2011
- Report Date
- April 12, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE IPG PASSED VISUAL INSPECTION. THE COMPLAINT OF DAMAGE TO THE IPG BECAUSE OF CARDIOVERSION PROCEDURE HAS BEEN CONFIRMED. THE ANALOG IC ((B)(4)) WAS DAMAGED. THE BATTERY DEPLETION RATE WITH STIMULATION OFF EXCEEDED THE TYPICAL BATTERY DEPLETION RATE. ALSO, THE DEVICE FAILED THE IMPEDANCE PORTION OF THE AUTOMATED TEST EQUIPMENT. DEPLETION RATE IS IN THE NORMAL RANGE PRIOR TO THE PATIENT'S CARDIOVERSION. AT THE APPROXIMATE DATE OF THE PROCEDURE, THE DEPLETION RATE CLIMBS MARKEDLY. THE (B)(4) DAMAGE RESULTED IN THE RAPID BATTERY DEPLETION RATE OF THE IPG. THE USE OF CARDIOVERSION RESULTED IN THE REPORTED COMPLAINT.
(B)(6).
A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES MAINTAINING A FULL CHARGE ON HER IPG. DURING TROUBLESHOOTING, THE BSN REPRESENTATIVE DETERMINED THAT THE IPG MAYBE DAMAGED FROM A CARDIOVERSION PROCEDURE. THE PHYSICIAN REPLACED THE IPG AND THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES MAINTAINING A FULL CHARGE ON HER IPG. DURING TROUBLESHOOTING, THE BSN REPRESENTATIVE DETERMINED THAT THE IPG MAYBE DAMAGED FROM A CARDIOVERSION PROCEDURE. THE PHYSICIAN REPLACED THE IPG AND THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
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 |