FDA Adverse Event Injury Summary report: N

LAMITRODE TRIPOLE 16

MDR report key: 3820875 · Received May 13, 2014

Report

Report Number: 1627487-2014-23306
Event Type: Injury
Date Received: May 13, 2014
Date of Event: April 18, 2014
Report Date: April 18, 2014
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: GZB
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL 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 MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 1 OF 3. REFERENCE MFR REPORT# 1627487-2014-23311, 23312. IT WAS REPORTED THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION. IT WAS ALSO REPORTED THE PT EXPERIENCING AT THE IPG SITE WHILE CHARGING. SUBSEQUENTLY, SHE UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014, WHERE HER SCS SYSTEM WAS REMOVED. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
286623	LAMITRODE TRIPOLE 16	SCS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3219	3595404

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR		Other