MAUDE MDR 2750451

MDR report key: 2750451
Report number: 1627487-2012-10506
Event key: 0
Event type: 3
Date of event: 2012-08-23
Date received: 2012-09-14
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: KARIN BECHLER
Address: 6901 PRESTON RD. PLANO TX 75024 US
Phone: 972-972-9723
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	ANCHOR	SCS LEAD ANCHOR	ST. JUDE MEDICAL - NEUROMODULATION	GYZ	1192		3571621				Y	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2012-09-14	0	1. R

Event Narratives#

D

Patient 1

DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-10505. THE PT ((B)(6)) RECEIVED A SURGICAL SCS LEAD AND LEAD ANCHOR FOR AN SCS TRIAL. IT WAS REPORTED, THE PT RECEIVED GOOD PARESTHESIA POST-OPERATIVELY UNTIL DAY THREE WHEN THE PT BEGAN TO FEEL STIMULATION IN THE ARM AND CHEST. THE CLINICIAN DECIDED THIS EVENT WAS A FAILED TRIAL AND ELECTED TO EXPLANT THE SCS LEAD AND LEAD ANCHOR. X-RAY IMAGERY CONFIRMED LEAD MIGRATION. FOLLOWING THE EXPLANT, THE PHYSICIAN REPORTED THE LEAD ANCHOR COULD BE UNLOCKED WITH VERY LITTLE TENSION.

N