FDA Adverse Event Injury Summary report: N

PRECISION®

MDR report key: 4940807 · Received July 25, 2015

Report

Report Number: 3006630150-2015-01932
Event Type: Injury
Date Received: July 25, 2015
Date of Event: July 1, 2015
Report Date: July 1, 2015
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

EXPLANTED DATE: (B)(6) 2014. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S INFECTION WAS LOCATED AT THE BACK, ON BOTH SITES. SYMPTOMS WERE FEVER, PAIN AND TIGHTNESS IN THE BACK. THE PATIENT WAS GIVEN ANTIBIOTICS INTRAVENOUSLY FOR 6 MONTHS. THERE WAS NO INFORMATION IF THE INFECTION WAS CAUSED BY THE DEVICE. THE PATIENT UNDERWENT AN ENTIRE SYSTEM EXPLANT. 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 #: 16920412, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. 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 MED WATCH WILL BE FILED.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED IN AN EMERGENCY SURGERY DUE TO A (B)(6) INFECTION.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS EXPLANTED IN AN EMERGENCY SURGERY DUE TO A (B)(6) INFECTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
484990	PRECISION®	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1110-02	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Required Intervention