MAUDE MDR 635425

MDR report key: 635425
Report number: 635425
Event key: 0
Event type: 3
Date of event: 2005-08-22
Date received: 2005-09-12
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Report source: U
Manufacturer link flag: N

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	UNK	UNK	UNK	BXM	UNK	UNK	UNK			Y		N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2005-09-12	0	1. O

Event Narratives#

D

Patient 1

EVENT OR PROBLEM: STIMULATOR REMOVAL.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K013215	BXM	MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM	Nuvasive, Inc.	2001-10-16
510(k)	K002677	BXM	NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM	Nuvasive, Inc.	2000-11-13
510(k)	K921498	BXM	VER MED A10011 PNS DUAL ELEMENT ELECTRODE	Vermont Medical, Inc.	1993-06-09
510(k)	K870662	BXM	MODEL SKCK STERILE KNOB COVER KIT	Life-Tech Intl., Inc.	1987-10-28