FDA Adverse Event Injury Summary report: N

PRECISION

MDR report key: 2000860 · Received February 17, 2011

Report

Report Number: 3006630150-2011-00231
Event Type: Injury
Date Received: February 17, 2011
Date of Event: December 9, 2010
Report Date: December 9, 2010
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION VALENCIA
Product Code: LGW
PMA / PMN Number: P030017
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT WAS EXPLANTED AND IS REPORTEDLY DOING WELL. THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE IPG FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT A PT WAS HAVING DIFFICULTIES CHARGING HER IPG. A BSN REP ANALYZED THE PT'S DATABASE AND SHOWED NO ABNORMALITIES. ADDITIONALLY, THE PT IS EXPERIENCING INEFFECTIVE THERAPY AS THE PHYSICIAN COULD NOT ORIGINALLY PLACE THE LEAD HIGH ENOUGH DUE TO SCAR TISSUE. THE PT OPTED TO HAVE THE ENTIRE SYSTEM EXPLANTED.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES CHARGING HER IPG. A BSN REPRESENTATIVE ANALYZED THE PATIENT'S DATABASE AND SHOWED NO ABNORMALITIES. ADDITIONALLY THE PATIENT IS EXPERIENCING INEFFECTIVE THERAPY AS THE PHYSICIAN COULD NOT ORIGINALLY PLACE THE LEAD HIGH ENOUGH DUE TO SCAR TISSUE. THE PATIENT OPTED TO HAVE THE ENTIRE SYSTEM EXPLANTED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Required Intervention