FDA Adverse Event Injury Summary report: N

OCTRODE

MDR report key: 2861086 · Received December 4, 2012

Report

Report Number: 1627487-2012-12610
Event Type: Injury
Date Received: December 4, 2012
Date of Event: November 12, 2012
Report Date: November 12, 2012
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

RESULTS - THE COMPLAINT FOR "INEFFECTIVE STIMULATION" WAS NOT CONFIRMED. AS REC'D, THE OCTRODE LEAD WAS CUT IN TWO SEGMENTS THAT WERE CONSISTENT WITH THE LEAD BEING EXPLANTED. BOTH LEAD SEGMENTS WERE INSPECTED UNDER THE MICROSCOPE. THE STIM END SEGMENT HAD A KINK BUT NO BROKEN WIRES WERE OBSERVED, TERMINAL END HAD A SLIGHT DISCOLORATION IN THE OUTER LEAD BODY. FUNCTIONAL TESTING OF THE LEAD SEGMENTS REVEALED THAT CONTINUITY PASSED FOR ALL CHANNELS OF THE TERMINAL END AND STIM END SEGMENTS. 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 2 OF 2. REFERENCE MFR REPORT #1627487-2012-12609. IT WAS REPORTED THE PT'S LEADS HAD MIGRATED AND THE PT WAS NO LONGER GETTING STIMULATION. THE PHYSICIAN RELOCATED ONE LEAD AND REPLACED THE OTHER LEAD AND REPLACED THE OTHER LEAD. NOTE THE PT HAS TWO LEADS WITH DIFFERENT LOT NUMBERS. IT IS UNK WHICH LEAD WAS EXPLANTED ON (B)(6) 2012. BOTH LEADS ARE BEING REPORTED. THE EXPLANTED LEAD WAS RETURNED TO SJM FOR EVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE	SCS LEAD	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3186	3715798

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention	SCS IPG: MODEL 3716\| IMPLANT DATE: