FDA Adverse Event Malfunction Summary report: N

PRECISION®

MDR report key: 3954037 · Received July 23, 2014

Report

Report Number: 3006630150-2014-01679
Event Type: Malfunction
Date Received: July 23, 2014
Date of Event: June 26, 2014
Report Date: July 1, 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 Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS NOT GOING TO BE EXPLANTED. THE PATIENT WAS SUPPOSEDLY TO UNDERGO REVISION PROCEDURE TO MOVE UP THE LEADS DUE TO NEED OF STIMULATION IN HER BACK. HOWEVER, THE PATIENT WILL NO LONGER PROCEED WITH THE REVISION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

Additional Manufacturer Narrative · 1

SC-1110-02 SN: (B)(4) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT WAS NOT VERIFIED. IN THE LAB, THE IPG WAS SUCCESSFULLY CHARGED TO FULL CAPACITY IN ONE CYCLE. THIS RESULT ATTESTED THAT THE DEVICE WAS CAPABLE OF BEING CHARGED FULLY UNDER A PROPER CHARGING METHOD. THE BATTERY DEPLETION RATE AND QUIESCENT CURRENT MEASURED NORMAL. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED AS THE IPG WAS NOT WORKING. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR IPG REPLACEMENT WAS DUE TO IPG NOT HOLDING A CHARGE. DEVICE MALFUNCTION WAS SUSPECTED.

Description of Event or Problem · 1