FDA Adverse Event Injury Summary report: N

OCTRODE

MDR report key: 3950234 · Received June 27, 2014

Report

Report Number: 1627487-2014-21332
Event Type: Injury
Date Received: June 27, 2014
Date of Event: May 8, 2013
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 4 OF 4. REFERENCE MFR REPORT: 1627487-2014-21329. REFERENCE MFR REPORT: 1627487-2014-21330. REFERENCE MFR REPORT: 1627487-2014-21331. IT WAS REPORTED, THE PT HAS NOT USED-CHARGED THE SCS SYS FOR APPROXIMATELY A YEAR DUE TO INEFFECTIVE STIMULATION. AS A RESULT, COMMUNICATION COULD NOT BE ESTABLISHED WITH THE IPG USING MULTIPLE EXTERNAL DEVICES. SURGICAL INTERVENTION TOOK PLACE TO EXPLANT AND REPLACE THE IPG. WHEN THE LEAD WAS TESTED INTRA-OPERATIVELY, ALL THE CONTACTS TESTED INVALID. THE PHYSICIAN OBSERVED THE ANCHOR WAS BROKEN AND THE LEAD WIRE WAS FRAYED. AS A RESULT, THE LEAD, EXTENSION, AND ANCHOR WERE EXPLANTED. PART OF THE ANCHOR WAS LEFT IMPLANTED DUE TO SCAR TISSUE. ADDITIONALLY, THE NEW LEAD (DEVICE 4) WAS UNABLE TO PROVIDE EFFECTIVE NECK STIMULATION INTRA-OPERATIVELY. THE PHYSICIAN DECIDED TO EXPLANT THE LEAD AND ABANDONED THE PROCEDURE. THE PT DOES NOT HAVE AN SCS SYS IMPLANTED AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
376597	OCTRODE	SCS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3186	4212932

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Other	IMPLANT DATE:\| SCS EXTENSION, MODEL 3386