FDA Adverse Event Injury Summary report: N

CHARGING SYSTEM

MDR report key: 3193626 · Received June 25, 2013

Report

Report Number: 1627487-2013-15847
Event Type: Injury
Date Received: June 25, 2013
Date of Event: June 3, 2013
Report Date: June 3, 2013
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Removal / Correction Number: 1627487-07262012-001-C
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THIS CHARGER MODEL WAS ASSOCIATED WITH A FIELD CORRECTION. MANUFACTURER'S EVALUATION: CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS PERFORMED. EVALUATION: RESULTS: POCKET HEATING WAS CONFIRMED. THE INVESTIGATION FOR CAPA (B)(4) ASSOCIATED WITH HEATING WHILE CHARGING (POCKET HEATING) CONCLUDED THAT THE CHARGER WAS CAPABLE OF TRANSFERRING ENERGY TO THE IPG AT A RATE THAT WOULD CAUSE HEATING OF THE IPG AND/OR CHARGING WAND OF SUFFICIENT ELEVATED TEMPERATURE TO CAUSE PAIN AND BURNS. THE HEATING WHILE CHARGING WAS DETERMINED TO BE EXACERBATED BY OFF-AXIS CHARGING OF SHALLOW IMPLANTED IPGS AND THAT ALL CHARGERS WERE CAPABLE OF ELEVATED HEATING. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-15846.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
287528	CHARGING SYSTEM	SCS CHARGING SYSTEM	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3721	3083186

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Other	SCS EXTENSION: MODEL 3386\| IMPLANT:\| IMPLANT:\| IMPLANT:\| SCS LEAD: MODEL 3186\| IMPLANT:\| SCS LEAD: MODEL 3186\| SCS EXTENSION: MODEL 3346