FDA Adverse Event Injury Summary report: N

OCTRODE

MDR report key: 3960425 · Received July 17, 2014

Report

Report Number: 1627487-2014-05507
Event Type: Injury
Date Received: July 17, 2014
Date of Event: June 25, 2014
Report Date: June 25, 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2014-05508. THE PATIENT HAD TWO LEADS FROM THE SAME LOT, AND TWO EXTENSIONS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT HAD LOST RIGHT SIDE COVERAGE ON THE MORNING OF (B)(6) 2014. THE PATIENT EVENTUALLY LOST STIMULATION EARLY THE FOLLOWING MORNING. AN IMPEDANCE CHECK REVEALED THE RIGHT LEAD HAD INVALID IMPEDANCE. REPROGRAMMING TO PROVIDE RESOLUTION WAS UNSUCCESSFUL. FOLLOW-UP REVEALED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014. DURING THE PROCEDURE, BOTH LEADS WERE FOUND TO BE FRACTURED ALONG WITH AN EXTENSION. AS A RESULT, BOTH LEADS AND THE FRACTURED EXTENSION WERE EXPLANTED/REPLACED. THE PATIENT STATED THAT HE PLAYED A FEW ROUNDS OF GOLF BEFORE THE STIMULATION ISSUES OCCURRED. THE DOCTOR BELIEVES THE DEVICES WERE FRACTURED DUE TO THE BIOMECHANICS OF THE PATIENT'S GOLF SWING. EFFECTIVE THERAPY WAS RESTORED POST-OP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
420349	OCTRODE	SCS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3189	4458965

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR		Other	SCS IPG: MODEL 3788\| IMPLANT DATE: