PRECISION®
Report
- Report Number
- 3006630150-2014-02373
- Event Type
- Injury
- Date Received
- October 18, 2014
- Date of Event
- September 15, 2014
- Report Date
- September 15, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DOES SUSPECT DEVICE MALFUNCTION OF THE STIMULATOR.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. THE PATIENT NO LONGER EXPERIENCED ANY SHOCKING SENSATION AFTER THE SURGERY. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.
SC-2218-70 SN:(B)(4) THE COMPLAINT WAS CONFIRMED. FIVE CABLES WERE FRACTURED CABLES AT THE BENT/KINKED SECTION OF THE LEAD BODY, 1 CM FROM THE CLIK ANCHOR SET SCREW MARK. THERE WERE NO EXPOSED CABLES. THE LEAD BODY WAS CUT DURING THE EXPLANT PROCEDURE, AND IT WAS NOT CONSIDERED AS A FAILURE. SC-2218-70 SN:(B)(4) THE COMPLAINT WAS CONFIRMED. SIX CABLES WERE FRACTURED CABLES AT THE BENT/KINKED SECTION OF THE LEAD BODY, 1 CM FROM THE CLIK ANCHOR SET SCREW MARK. THERE WERE NO EXPOSED CABLES. THE LEAD BODY WAS BURNED DURING THE EXPLANT PROCEDURE, AND IT WAS NOT CONSIDERED AS A FAILURE. SC-1110-02 SN:(B)(4) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES.
A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD IMPEDANCES CHANGED VERY DRAMATICALLY WITH POSITION. THE PATIENT WAS EXPERIENCING SHOCKING SENSATION AND LOSS OF STIMULATION WHEN THERE WAS A CHANGED IN POSITION. IT WAS ALSO REPORTED THAT THE PHYSICIAN WANTED A REVISION FOR THE PATIENT BECAUSE THE IPG AND THE LEADS WERE NOT WORKING PROPERLY. THE PATIENT WILL UNDERGO A LEAD AND IPG REPLACEMENT.
A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD IMPEDANCES CHANGED VERY DRAMATICALLY WITH POSITION. THE PATIENT WAS EXPERIENCING SHOCKING SENSATION AND LOSS OF STIMULATION WHEN THERE WAS A CHANGED IN POSITION. IT WAS ALSO REPORTED THAT THE PHYSICIAN WANTED A REVISION FOR THE PATIENT BECAUSE THE IPG AND THE LEADS WERE NOT WORKING PROPERLY. THE PATIENT WILL UNDERGO A LEAD AND IPG REPLACEMENT.
A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD IMPEDANCES CHANGED VERY DRAMATICALLY WITH POSITION. THE PATIENT WAS EXPERIENCING SHOCKING SENSATION AND LOSS OF STIMULATION WHEN THERE WAS A CHANGED IN POSITION. IT WAS ALSO REPORTED THAT THE PHYSICIAN WANTED A REVISION FOR THE PATIENT BECAUSE THE IPG AND THE LEADS WERE NOT WORKING PROPERLY. THE PATIENT WILL UNDERGO A LEAD AND IPG REPLACEMENT.
A REPORT WAS RECEIVED THAT THE PATIENT¿S LEAD IMPEDANCES CHANGED VERY DRAMATICALLY WITH POSITION. THE PATIENT WAS EXPERIENCING SHOCKING SENSATION AND LOSS OF STIMULATION WHEN THERE WAS A CHANGED IN POSITION. IT WAS ALSO REPORTED THAT THE PHYSICIAN WANTED A REVISION FOR THE PATIENT BECAUSE THE IPG AND THE LEADS WERE NOT WORKING PROPERLY. THE PATIENT WILL UNDERGO A LEAD AND IPG REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663754 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |