FDA Adverse Event Injury Summary report: N

PENTA

MDR report key: 3850519 · Received May 30, 2014

Report

Report Number: 1627487-2014-01366
Event Type: Injury
Date Received: May 30, 2014
Date of Event: May 8, 2014
Report Date: May 8, 2014
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: GZB
PMA / PMN Number: P010032
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

SJM HAS LIMITED INFORMATION 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 2. REFERENCE MFR REPORT# 1627487-2014-01367. IT WAS REPORTED THE PT LOST RIGHT SIDE STIMULATION. X-RAYS REVEALED THE LEAD WIRES WERE COILED UP NEAR THE IPG AND LEAD SITES. THER WERE NO REPORTED FALLS OR KNOWN INJURIES BY THE PT. DIAGNOSTIC TESTING IDENTIFIED INVALID IMPEDANCE. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A FUTURE DATE. F/U IDENTIFIED THE X-RAY REVEALED A LEAD MIGRATION. REPORTEDLY, THE IPG WAS ALSO MOVING AROUND IN THE POCKET AND TWISTED IN THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014. THE IPG AND LEAD WERE EXPLANTED AND REPLACED. THE ORIGINAL IPG WOULD NOT ESTABLISH COMMUNICATION PRE-OPERATIVELY OR INTRA-OPERATIVELY. SUBSEQUENTLY, THE IPG WAS REPLACED WITH A NON-RECHARGEABLE DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
319715	PENTA	SCS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3228	4319337

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Other