FDA Adverse Event Injury Summary report: N

PRECISION

MDR report key: 1921606 · Received December 8, 2010

Report

Report Number: 3006630150-2010-02095
Event Type: Injury
Date Received: December 8, 2010
Date of Event: November 12, 2010
Report Date: November 12, 2010
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P030017
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITION INFORMATION RECEIVED THAT THE PATIENT UNDERWENT A LEAD REVISION. THE PHYSICIAN CHOSE TO EXPLANT THE LEADS AND IMPLANT A PADDLE LEAD. AS THE PHYSICIAN WAS EXPLANTING THE LEADS, ONE OF THE LEADS BEGAN TO FALL APART FROM HIM MESSING WITH IT AND THEN PART OF IT GOT STUCK INSIDE THE PATIENT. THE LEAD WAS CUT AND A PART OF THE LEAD REMAINS IN THE PATIENT AND WILL NOT BE REMOVED. THE LEAD (SN# (B)(4)) PASSED VISUAL, PHOTOGRAPHIC IMAGING, ELECTRICAL AND MECHANICAL TESTS PERFORMED. THE LEAD EXHIBITS NORMAL DEVICE CHARACTERISTIC. THE LEAD (SN# (B)(4)) WAS CUT AND DISTAL END IS MISSING. THE DAMAGE TO THE LEAD IS CONSISTENT WITH DAMAGES DURING THE EXPLANT PROCEDURE AND IS NOT CONSIDERED A FAILURE.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT A PATIENT WILL UNDERGO A LEAD REPLACEMENT PROCEDURE DUE TO FIVE CONTACTS BEING OUT RESULTING IN HIGH IMPEDANCES.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT A PT WILL UNDERGO A LEAD REPLACEMENT PROCEDURE DUE TO FIVE CONTACTS BEING OUT RESULTING IN HIGH IMPEDANCES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PRECISION	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-2208-50	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention	MODEL #: SC-2208-50\| ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.012" STYLET\| SERIAL #: (B)(4)