FDA Adverse Event Injury Summary report: N

PRECISION

MDR report key: 1933777 · Received December 16, 2010

Report

Report Number: 3006630150-2010-02102
Event Type: Injury
Date Received: December 16, 2010
Date of Event: November 15, 2010
Report Date: November 15, 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: WI, US
Reporter Occupation: MEDICAL ASSISTANT

Narratives

Additional Manufacturer Narrative · 1

A RETURN PRODUCT ANALYSIS SHOWED BURN MARKS ON THE IPG CASE AND THE ANALOG IC HAD AN INTERNAL SHORT(S) RESULTING IN EXCESSIVE CURRENT DRAIN OF THE BATTERY. ELECTROCAUTERY WAS NOT USED AND NO PRIOR REVISIONS OCCURRED THAT MAY HAVE RESULTED IN THE ANALOG IC DAMAGE. THE VISUAL BURN MARKS AND RAPID BATTERY DEPLETION WAS MOST LIKELY A RESULT OF ELECTROCAUTERY USE DURING THE EXPLANT PROCEDURE. THE REPORTED COMPLAINT OF FREQUENT IPG CHARGING COULD NOT BE CONFIRMED. MONOPOLAR ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH-VOLTAGE TRANSIENT SIGNAL AND CURRENT LABELING WARNS AGAINST THE USE OF MONOPOLAR ELECTROCAUTERY (REFER TO PHYSICIAN'S IMPLANT MANUAL (B)(4) REV. AB).

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PT'S IPG WAS DEPLETING QUICKLY. A DATABASE ANALYSIS INDICATED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE PHYSICIAN REPLACED THE IPG AND THE PT WAS REPORTEDLY DOING FINE.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS DEPLETING QUICKLY. A DATABASE ANALYSIS INDICATED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE PHYSICIAN REPLACED THE IPG AND THE PATIENT WAS 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	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention