FDA Adverse Event Injury Summary report: N

OCTRODE PERCUTANEOUS LEAD

MDR report key: 2140984 · Received June 21, 2011

Report

Report Number: 1627487-2011-03116
Event Type: Injury
Date Received: June 21, 2011
Date of Event: May 23, 2011
Report Date: May 23, 2011
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
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

PT RECEIVED A SCS SYSTEM INCLUDING TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) ON (B)(6) 2010. IT WAS REPORTED THAT THE PT FELT AN OVER-STIMULATION SENSATION. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. X-RAYS REVEALED LEADS HAD MIGRATED. FOLLOW UP ON THE PT FOUND THAT THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE PT'S LEADS ON (B)(6) 2011. THE LEADS HAD ALLEGEDLY MIGRATED DOWN SEVERAL VERTEBRAL BODIES WHICH MADE THEM DIFFICULT TO REPOSITION. THE EXPLANTED LEADS WERE DISCARDED BY THE FACILITY. NO FURTHER PT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE PERCUTANEOUS LEAD	SPINAL CORD STIMULATION LEAD	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3186	2854840

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Required Intervention	IMPLANTED:\| IMPLANTED:\| SCS ANCHOR: MODEL 1192 (2)\| SCS IPG: MODEL 3788