FDA Adverse Event Injury Summary report: N

OCTRODE

MDR report key: 2861065 · Received December 3, 2012

Report

Report Number: 1627487-2012-02744
Event Type: Injury
Date Received: December 3, 2012
Date of Event: November 6, 2012
Report Date: November 7, 2012
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-02743. THE PT RECEIVED HIS SCS SYSTEM FOR SHOULDER PAIN. IT WAS REPORTED WHEN THE PT TURNS ON STIMULATION, IT BEGINS IN HIS FINGERS AND MOVES TO HIS SHOULDER AS HE INCREASES STIMULATION. HE STATED IN ORDER TO FEEL STIMULATION IN HIS SHOULDER, HE MUST TURN STIMULATION UP SO HIGH IT FEELS LIKE IT SHOCKS HIM AND CAUSES SEIZURE-LIKE SYMPTOMS. WHEN STIMULATION WAS TURNED UP TO THIS LEVEL HE ALLEGEDLY IS UNABLE TO GRASP HIS PROGRAMMER AND TO WALK AND HE CAN BARELY STAND. HE STATED HE FELT THE OVERSTIMULATION WAS IN HIS ENTIRE BODY. HE ALSO REPORTED WHEN HE ATTEMPTED TO INCREASE THE AMPLITUDE ON (B)(4) 2012, TWO OF HIS PROGRAMS AUTO-REDUCED AND THE THIRD PROGRAM WAS NON-FUNCTIONAL. FOLLOW-UP IDENTIFIED THE PT WAS REPROGRAMMED BUT STATES THE SHOULDER/UPPER ARM STIMULATION IS NOT HIGH ENOUGH. IT WAS REPORTED THE PT PLANNED TO CONSULT WITH HIS PHYSICIAN REGARDING THE ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE	SCS LEAD	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3189	3308930

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Required Intervention	SCS ANCHOR: MODEL 1192\| IMPLANT DATE: