FDA Adverse Event Injury Summary report: N

PRECISION®

MDR report key: 3781352 · Received April 30, 2014

Report

Report Number: 3006630150-2014-00921
Event Type: Injury
Date Received: April 30, 2014
Date of Event: April 1, 2014
Report Date: April 1, 2014
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #:SC-2218-50, SERIAL #: (B)(4), DESCRIPTION:LINEAR ST LEAD, 50CM.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR THE EXPLANT PROCEDURE WAS PATIENT PREFERENCE. THE PATIENT WAS HAVING INADEQUATE STIMULATION.

Additional Manufacturer Narrative · 1

SC-1110-02 ((B)(4)) DEVICE EVALUATION INDICATED THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TEST PERFORMED. THE IPG EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-2218-50 ((B)(4)) DEVICE EVALUATION INDICATED THAT THE DAMAGE TO THE LEADS WAS CONSISTENT WITH DAMAGES DONE DURING THE EXPLANT PROCEDURE AND IT WAS NOT CONSIDERED A FAILURE. SC-4316 VISUAL INSPECTION OF THE CLIK ANCHORS REVEALED THAT BOTH HAVE ONE TORN EYELET. NO PARTS OF THE ANCHORS WERE MISSING.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE DUE TO UNKNOWN REASON.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE DUE TO UNKNOWN REASON.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE DUE TO UNKNOWN REASON.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
259403	PRECISION®	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1110-02	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Required Intervention