FDA Adverse Event Injury Summary report: N

OCTRODE

MDR report key: 2894861 · Received December 20, 2012

Report

Report Number: 1627487-2012-02860
Event Type: Injury
Date Received: December 20, 2012
Date of Event: November 27, 2012
Report Date: November 27, 2012
Manufacturer: ST. JUDE MEDICLA - NEUROMODULATION
Product Code: GZB
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 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 3 OF 3. REFERENCE MFR REPORTS: 1627487-2012-02858, 02859. IT WAS REPORTED, THE PT EXPERIENCED COMMUNICATION ISSUES WITH HIS IPG. HE STATED, HE FELL DOWN THE STAIRS ABOUT 4 WEEKS AGO AND A WEEK LATER, HE FELT A "BITING" SENSATION AROUND THE IPG SITE WITH STIMULATION ON. THE PT ALSO REPORTED, HE DID NOT HAVE ADEQUATE STIMULATION COVERAGE ANY LONGER IN HIS UPPER BACK. REPROGRAMMING WAS UNABLE TO RESOLVE THE UNCOMFORTABLE SENSATION NOR THE INADEQUATE COVERAGE. THE PT STATED, THE PAIN IS UNBEARABLE AND HE WANTS HIS SYSTEM REMOVED. DIAGNOSTIC TESTING REVEALED NO ANOMALIES. IT WAS REPORTED X-RAYS HAVE BEEN ORDERED AND A REVISION SURGERY IS BEING CONSIDERED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE	SCS LEAD	GZB	ST. JUDE MEDICLA - NEUROMODULATION	3186	3093078

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Required Intervention