FDA Adverse Event Injury Summary report: N

PRECISION®

MDR report key: 2893674 · Received January 2, 2013

Report

Report Number: 3006630150-2012-02442
Event Type: Injury
Date Received: January 2, 2013
Date of Event: December 11, 2012
Report Date: December 11, 2012
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM; MODEL #: SC-4316, LOT #: 15320268, 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 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.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO PROCEDURE RELATED METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT'S SYMPTOM WAS VISIBLE INFECTION AT THE POCKET SITE AND THE INFECTION HAS SPREAD SYSTEMICALLY. THE PATIENT WAS GIVEN INTRAVENOUS ANTIBIOTICS AND WAS REPORTEDLY STILL IN THE HOSPITAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
154	PRECISION®	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1110-02	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR		Hospitalization\| R