FDA Adverse Event Injury Summary report: N

QUATTRODE LEAD WIRE SPACED, 60 CM

MDR report key: 2041076 · Received March 29, 2011

Report

Report Number: 1627487-2011-00420
Event Type: Injury
Date Received: March 29, 2011
Date of Event: February 28, 2011
Report Date: February 28, 2011
Manufacturer: ST JUDE MEDICAL - NEUROMODULATION DIVISION
Product Code: GZB
PMA / PMN Number: K072462
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: OTHER

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 2 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00419 AND 1627487-2011-00421. THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2010, INCLUDING TWO PERCUTANEOUS LEADS AND A LEAD EXTENSION. IT WAS REPORTED THAT THE PT RECENTLY SUFFERED A FALL AND IS EXPERIENCING DISCOMFORT AT THE SITE WHERE THE LEADS ARE LOCATED. AN X-RAY REVEALED THAT THE PT'S LEADS HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO CORRECT THIS ISSUE. AT THAT TIME, THE LEADS IN QUESTION AND THE ASSOCIATED EXTENSION WERE REPLACED. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED TO THE MANUFACTURER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUATTRODE LEAD WIRE SPACED, 60 CM	SPINAL CORD STIMULATION LEAD	GZB	ST JUDE MEDICAL - NEUROMODULATION DIVISION	3166	3108715

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Required Intervention	IMPLANT:\| SCS IPG: MODEL 3788\| SCS LEAD: MODEL 3186\| IMPLANT: