FDA Adverse Event Injury Summary report: N

LAMITRODE S8

MDR report key: 3810701 · Received April 28, 2014

Report

Report Number: 1627487-2014-26355
Event Type: Injury
Date Received: April 28, 2014
Date of Event: March 31, 2014
Report Date: April 6, 2014
Manufacturer: ST. JUDE MEDICAL - 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 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: 1627487-2014-26356. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION AND WAS HOSPITALIZED. THE PATIENT HAS BEEN SEEN BY A SJM REPRESENTATIVE TO ADJUST STIMULATION BUT THE PAIN REMAINS UNCONTROLLED. THE PATIENT REPORTS SOME OF THE PROGRAMS ARE NO LONGER FUNCTIONING. DIAGNOSTIC TESTING IDENTIFIED MULTIPLE INVALID ELECTRODES. REPROGRAMMING WAS ABLE TO PROVIDE ADEQUATE STIMULATION. FOLLOW UP ON THIS MATTER REVEALED THAT THE PATIENT ATTRIBUTED THE CHANGE IN STIMULATION TO THE DYE USED FOR THE CT SCAN. AN INTERROGATION OF THE SCS SYSTEM SHOWED THAT ONE OF THE LEADS IS INVALID AND THE OTHER LEAD HAS 4 FUNCTIONAL ELECTRODES. THE PATIENT IS RECEIVING EFFECTIVE STIMULATION; HOWEVER, HE IS EXPERIENCING ADDITIONAL PAIN THOUGHT TO BE DUE TO DEGENERATIVE SPINE ISSUES. IT HAS BEEN NOTED THE PATIENT MAY UNDERGO SPINE SURGERY UNRELATED TO THIS ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
253965	LAMITRODE S8	SCS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3286	3761856

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Hospitalization	SCS IPG: MODEL 3788\| IMPLANT DATE:\| IMPLANT DATE:\| SCS ANCHOR: MODEL 1192 (2)