FDA Adverse Event Injury Summary report: N

PRECISION®

MDR report key: 3093046 · Received May 3, 2013

Report

Report Number: 3006630150-2013-00873
Event Type: Injury
Date Received: May 3, 2013
Date of Event: April 12, 2013
Report Date: April 12, 2013
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL / LOT #: (B)(4)/488679, DESCRIPTION: LINEAR ST LEAD, 70CM. 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.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE INITIAL SYMPTOM OF POCKET EROSION WAS DISCOMFORT DUE TO THE BELT RUBBING ON THE POCKET SITE. THE PATIENT WAS DOING WELL FOLLOWING THE EXPLANT PROCEDURE.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT HAD SKIN EROSION AT THE POCKET SITE. THE PATIENT WAS GIVEN ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT HAD SKIN EROSION AT THE POCKET SITE. THE PATIENT WAS GIVEN ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
193826	PRECISION®	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1110-02	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Required Intervention