FDA Adverse Event Injury Summary report: N

OCTRODE

MDR report key: 3810481 · Received May 6, 2014

Report

Report Number: 1627487-2014-25347
Event Type: Injury
Date Received: May 6, 2014
Date of Event: April 9, 2014
Report Date: April 14, 2014
Manufacturer: ST. JUDE MEDICAL- NEUROMODULATION
Product Code: GZB
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, 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

DEVICE 2 OF 2. REFERENCE MFR REPORT NUMBER: 1627487-2014-25346. THE PATIENT HAS TWO LEADS WITH THE SAME LOT NUMBER. THE PT REPORTED EXPERIENCING PAIN AND DISCOMFORT AT THE IPG SITE REGARDLESS OF STIMULATION. IT WAS ALSO REPORTED THE PT FEELS LIKE THE IPG HAS MOVED. AN SJM REP MET WITH THE PT FOR EVAL. DURING THE VISIT, THE PT REPORTED FALLING THREE MONTHS AGO AND EXPERIENCING INEFFECTIVE STIMULATION/COVERAGE. DIAGNOSTICS REVEALED LOW IMPEDANCES. IN TURN, THE PATIENT'S LEADS MAY HAVE PULLED OUT THE IPG HEADER AND HAVE FLUID INTRUSION BUT IS NOT CONFIRMED. ADDITIONALLY, THE PATIENT REPORTED USING (B)(6) PATCHES BUT IT DID NOT PROVIDE PAIN RELIEF. IN TURN, THE PHYSICIAN PLANS TO ADMINISTER POINT INJECTIONS TO ALLEVIATE THE PAIN. FOLLOW-UP REVEALED, THE PATIENT'S PAIN HAS RESOLVED AND IT WAS DETERMINED TO BE SCIATICA. IT WAS ALSO REPORTED THE PT CONTINUES TO HAVE DISCOMFORT BUT WILL NOT SEEK INTERVENTION AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
271809	OCTRODE	SCS LEAD	GZB	ST. JUDE MEDICAL- NEUROMODULATION	3189	2847762

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Other	IMPLANT DATE:\| SCS ANCHORS: MODEL 1194 (X2)