FDA Adverse Event Injury Summary report: N

PRECISION®

MDR report key: 3270379 · Received August 8, 2013

Report

Report Number: 3006630150-2013-01622
Event Type: Injury
Date Received: August 8, 2013
Date of Event: July 15, 2013
Report Date: July 15, 2013
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD AN EXPLANT PROCEDURE WITH AN UNKNOWN REASON. DEVICE EVALUATION INDICATED THAT THE LEADS WERE CUT APPROXIMATELY THREE INCHES FROM THE PROXIMAL ENDS. THE DISTAL PORTION OF THE LEADS WERE NOT RETURNED. DAMAGE TO THE LEADS WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND WAS NOT CONSIDERED A FAILURE.

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2208-70 SERIAL #: (B)(4), DESCRIPTION: ST LINEAR LEAD 70CM.

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2208-70, SERIAL #: (B)(4), DESCRIPTION: ST LINEAR LEAD 70CM.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S SYMPTOMS WERE REDNESS AT POCKET SITE AND SLIGHT FEVER. IV ANTIBIOTICS WERE PRESCRIBED DURING THE PROCEDURE. THE PHYSICIAN BELIEVED THAT INFECTION WAS NOT DEVICE RELATED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AT THE POCKET SITE.

Description of Event or Problem · 1