PRECISION SPECTRA

MDR report key: 6097075 · Received November 11, 2016

Report

Report Number: 3006630150-2016-03327
Event Type: Injury
Date Received: November 11, 2016
Date of Event: October 13, 2016
Report Date: October 13, 2016
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WERE REPLACED DUE TO POOR PADDLE PLACEMENT AND INABILITY TO GET COVERAGE. REASON FOR IPG REPLACEMENT WAS UNKNOWN. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-1132 SERIAL #: 113556 DESCRIPTION: PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR IPG REPLACEMENT WAS DUE TO DIFFICULTY CHARGING. THE PHYSICIAN BELIEVED THAT THE DEVICE WAS NEARLY END OF LIFE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INFORMATION COULD BE OBTAINED.