PRECISION®
Report
- Report Number
- 3006630150-2012-01803
- Event Type
- Injury
- Date Received
- September 26, 2012
- Date of Event
- March 23, 2012
- Report Date
- September 4, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN INDICATED THAT THE ITCHING WAS NOT DEVICE RELATED.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.
DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL,OPERATIONAL AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. BASED ON THE BATTERY AND CHARGE PROFILES, IT APPEARS THAT THE DEVICE EXHIBITS NORMAL CHARACTERISTICS PRIOR THE EXPLANT PROCEDURE. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE EXPLANT PROCEDURE. THE AIC WAS DAMAGED AND IT RESULTED IN THE RAPID BATTERY DEPLETION POST EXPLANT. THE MONOPOLAR ELECTROCAUTERY PROCEDURES ARE A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL THAT CAN DAMAGE THE AIC-U1. DEVICE EVALUATION INDICATED THAT THE LEAD WAS DAMAGED AND IS CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND ARE NOT CONSIDERED A FAILURE.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO ITCHING ON HER ARMS AND LEGS.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO ITCHING ON HER ARMS AND LEGS.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO ITCHING ON HER ARMS AND LEGS.
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 | 53 YR | Required Intervention |