PRECISION®

Report

Report Number: 3006630150-2011-00943
Event Type: Injury
Date Received: June 28, 2011
Date of Event: May 31, 2011
Report Date: June 7, 2011
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, PERFORMANCE TESTS PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG FOUND THEM TO BE SATISFACTORY.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO EROSION AT THE POCKET SITE. THE SKIN UNDER THE INCISION SITE OF THE IPG HAD ERODED AND THE IPG WAS VISIBLE THROUGH THE SKIN. THE PATIENT'S SYMPTOMS INCLUDED PAIN AND DRAINAGE. THE SITE BELOW THE POCKET WAS DEBRIDED. THE PATIENT WAS GIVEN ORAL AND IV ANTIBIOTICS AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO EROSION AT THE POCKET SITE. THE SKIN UNDER THE INCISION SITE OF THE IPG HAD ERODED AND THE IPG WAS VISIBLE THROUGH THE SKIN. THE PATIENT'S SYMPTOMS INCLUDED PAIN AND DRAINAGE. THE SITE BELOW THE POCKET WAS DEBRIDED. THE PATIENT WAS GIVEN ORAL AND IV ANTIBIOTICS AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PRECISION®	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1110-02	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Hospitalization\| R