PRECISION®
Report
- Report Number
- 3006630150-2011-00770
- Event Type
- Injury
- Date Received
- June 1, 2011
- Report Date
- April 22, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(6).
A RETURNED PRODUCT ANALYSIS INDICATED THAT THE DEVICE PASSED ALL VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INTERMITTENT AND PAINFUL SENSATION OF HEAT AT THE IPG SITE WHICH BEGAN FOLLOWING A SPINAL FUSION PROCEDURE PERFORMED IN (B)(6) 2010. A BSN ENGINEER ANALYZED THE PATIENT'S DATABASE AND FOUND NO ANOMALIES. THE IPG TEMPERATURE HISTORY WAS HIGHER THAN GENERALLY OBSERVED, BUT WITHIN DEVICE LIMITS. THIS INCREASE MAY BE RELATED TO CHARGING TECHNIQUE. THE PHYSICIAN DECIDED TO REPLACE THE PATIENT'S IPG AND THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INTERMITTENT AND PAINFUL SENSATION OF HEAT AT THE IPG SITE WHICH BEGAN FOLLOWING A SPINAL FUSION PROCEDURE PERFORMED IN (B)(6) 2010. A BSN ENGINEER ANALYZED THE PATIENT'S DATABASE AND FOUND NO ANOMALIES. THE IPG TEMPERATURE HISTORY WAS HIGHER THAN GENERALLY OBSERVED, BUT WITHIN DEVICE LIMITS. THIS INCREASE MAY BE RELATED TO CHARGING TECHNIQUE. THE PHYSICIAN DECIDED TO REPLACE THE PATIENT'S IPG AND THE PATIENT IS 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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |