FDA Adverse Event Injury Summary report: N

LAMITRODE TRIPOLE 16

MDR report key: 3962492 · Received July 14, 2014

Report

Report Number: 1627487-2014-00426
Event Type: Injury
Date Received: July 14, 2014
Date of Event: April 25, 2014
Report Date: June 18, 2014
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: GZB
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
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

IT WAS REPORTED THE PATIENT ((B)(6)) EXPERIENCED OVERSTIMULATION AND PAIN FROM HER THERAPY SYSTEM. THE DISCOMFORT IS REPORTEDLY FELT DOWN THE PATIENT'S LEG. IN ADDITION, IT WAS REPORTED THE PATIENT WAS LOSING FEELING IN HER LEG CAUSING HER TO COLLAPSE. THESE ISSUES REPORTEDLY OCCUR REGARDLESS OF THE STIMULATION'S USE. A DIAGNOSTIC TEST FOUND NO ISSUES WITH RESPECT TO IMPEDANCE MEASUREMENTS. SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT THE PATIENT'S THERAPY SYSTEM. HOWEVER, THE PAIN AND OVERSTIMULATION REPORTEDLY CONTINUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
409254	LAMITRODE TRIPOLE 16	SCS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3219	3710171

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	IMPLANT DATE:\| SCS IPG: MODEL 3788\| IMPLANT DATE:\| SCS ANCHOR: MODEL 1192