FDA Adverse Event Injury Summary report: N

PRECISION®

MDR report key: 2140012 · Received June 25, 2011

Report

Report Number: 3006630150-2011-00933
Event Type: Injury
Date Received: June 25, 2011
Date of Event: April 27, 2011
Report Date: June 3, 2011
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-2218-50 SERIAL#: (B)(4) MODEL DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH. STYLET MODEL#:SC-2218-70 SERIAL# :(B)(4) MODEL DESCRIPTION:ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014 INCH. STYLET MODEL#:SC-4316 SERIAL#: (B)(4) MODEL DESCRIPTION: CLIK ANCHOR (SET OF 2) THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY.

Additional Manufacturer Narrative · 1

A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION AT THE POCKET SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND REPORTEDLY DOING FINE.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION AT THE POCKET SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND REPORTEDLY DOING FINE.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention