FDA Adverse Event Malfunction Summary report: N

PRECISION®

MDR report key: 2930776 · Received January 28, 2013

Report

Report Number: 3006630150-2013-00152
Event Type: Malfunction
Date Received: January 28, 2013
Date of Event: October 16, 2012
Report Date: October 16, 2012
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM; SC-2218-50 (SERIAL # (B)(4)). THE SOURCE OF THE COMPLAINT WAS VERIFIED TO BE THE ASSOCIATED LEADS THAT WERE FRACTURED/BROKEN AT THE SUTURE SITES. SC-1110-02 (SERIAL # (B)(4)). THE IPG HAS ELECTROCAUTERY BURN MARKS ON THE CASE. THE DEVICE PROFILE INDICATED NO ANOMALIES PRIOR TO THE EXPLANT PROCEDURE. THE DEVICE EXHIBITED HIGH SLEEP CURRENT AND LOW IMPEDANCE DUE TO ANALOG INTEGRATED CIRCUIT (AIC) DAMAGE. EXPOSING AIC TO HIGH-ELECTROMAGNETIC OR VOLTAGE TRANSIENT CAN CAUSE THIS TYPE OF FAILURE. IT WAS UNKNOWN IF ELECTROCAUTERY WAS USED DURING THE EXPLANT PROCEDURE. SC-4316 DEVICE EVALUATION INDICATED THAT THE CLIK ANCHOR PASSED THE MECHANICAL TEST PERFORMED. THE CLIK ANCHOR WAS LOCKED ONTO A SAMPLE LEAD AND TESTED FOR SLIPPAGE. NO ANOMALIES WERE FOUND.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING LOSS OF STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PERCUTANEOUS LEADS WERE REPLACED WITH A NEW PADDLE LEAD. THE IPG WAS ALSO REPLACED PER THE PHYSICIAN'S PREFERENCE. THE PATIENT WAS DOING FINE POSTOPERATIVELY. DURING PRODUCT ANALYSIS, IT WAS DISCOVERED THAT THE LEADS WERE FRACTURED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
36756	PRECISION®	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-2218-50	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR