FDA Adverse Event Injury Summary report: N

PRECISION®

MDR report key: 3965320 · Received July 29, 2014

Report

Report Number: 3006630150-2014-01715
Event Type: Injury
Date Received: July 29, 2014
Date of Event: July 7, 2014
Report Date: July 7, 2014
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR EXPLANT WAS THAT THE PATIENT NO LONGER WANTED TO USE THE IMPLANT. NO DEVICE MALFUNCTION WAS SUSPECTED.

Additional Manufacturer Narrative · 1

DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. SC-8216-50 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE LEAD PASSED PHOTOGRAPHIC IMAGING TEST PERFORMED. DAMAGE TO THE LEAD WAS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT WAS NOT CONSIDERED A FAILURE.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR UNKNOWN REASON.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR UNKNOWN REASON.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR UNKNOWN REASON.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
441636	PRECISION®	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1110-02	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Required Intervention