PRECISION®

Report

Report Number: 3006630150-2014-02157
Event Type: Injury
Date Received: September 23, 2014
Date of Event: August 12, 2014
Report Date: August 12, 2014
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 Manufacturer Narrative · 1

SC-1110-02 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE POSSIBILITY THAT ELECTRICAL LEAKAGE COULD CAUSE HEATING AND/OR PAIN AT THE PATIENT¿S POCKET SITE WAS INVESTIGATED. THE DEVICE OUTPUT WAS MONITORED FOR EXCESSIVE LEAKAGE CURRENT OR SPURIOUS SIGNALS IN A SALINE SOLUTION, WHILE PROGRAMMED TO THE PATIENT¿S LATEST SETTING. LEAKAGE CURRENT WAS IN THE NORMAL RANGE. THEREFORE, THE REPORTED COMPLAINT OF THE IPG CAUSING BURNING PAIN AND OR HEATING AT THE POCKET SITE WAS NOT DUPLICATED OR CONFIRMED.

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL : SC-5312, SERIAL/LOT : (B)(4), DESCRIPTION: SCS CHARGER 2.0, MODEL : SC-2218-50, SERIAL/LOT: (B)(4),DESCRIPTION: LINEAR ST LEAD, 50CM. IT IS INDICATED THAT THE CHARGER WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE 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.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE AND BURNING SENSATION WHEN CHARGING. DEVICE MALFUNCTION WAS SUSPECTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM; MODEL#: SC-4316, LOT #:14706339, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. 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 MEDWATCH WILL BE FILED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DID NOT SUSPECT DEVICE MALFUNCTION.