FDA Adverse Event Injury Summary report: N

CHARGING SYSTEM

MDR report key: 2903194 · Received January 2, 2013

Report

Report Number: 1627487-2013-13001
Event Type: Injury
Date Received: January 2, 2013
Date of Event: December 4, 2012
Report Date: December 4, 2012
Manufacturer: ST JUDE MED - 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: CT, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THIS CHARGER MODEL WAS ASSOCIATED WITH A FIELD CORRECTION. MFR'S EVAL: CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS PERFORMED. EVAL: 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 TEMPT TO CAUSE PAIN AND BURNS. THE HEATING WHILE CHARGING WAS DETERMINED TO BE EXACERBATED BY OFF-AXIS CHARGING OF SHALLOW IMPLANTED IPG'S AND THAT ALL CHARGERS WERE CAPABLE OF ELEVATED HEATING. SJM HAS LIMITED INFO RELATED TO THE PT'S MED HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MED HISTORY.

Description of Event or Problem · 1

DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-13002. IT WAS REPORTED BY THE PT THE CHARGING SYS WOULD GET HOT WHILE CHARGING. MULTIPLE ATTEMPTS TO CONTACT THE PT WERE UNSUCCESSFUL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
306	CHARGING SYSTEM	SCS CHARGING SYSTEM	LGW	ST JUDE MED - NEUROMODULATION	3721	2791325

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Required Intervention	SCS LEAD, MODEL 3146 (2)\| IMPLANT:\| SCS EXTENSION, MODEL 3342\| IMPLANT:\| IMPLANT:\| SCS LEAD, MODEL 3186