MAUDE MDR 2628891

MDR report key: 2628891
Report number: MW5025932
Event key: 0
Event type: 3
Date of event: 2007-11-01
Date received: 2012-06-25
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 305
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Report source: P
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	EBI BONE STIMULATOR	BONE STIMULATOR	MEDICAL INC	LOE

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2012-06-25	0

Event Narratives#

D

Patient 1

PT HAD A SPINAL FUSION ON (B)(6) 2007. A BONE STIMULATOR WAS IMPLANTED WITH LEAD INTO THE SPINE. IN (B)(6) 2007, NEUROLOGICAL SURGEON SENT HIM TO DO MRI. DURING THE MRI THE LEAD FROM THE IMPLANTED BONE STIMULATOR BECAME VERY HOT AND UNBEARABLE AND PT HAD TO STOP PROCEDURE. AFTER THIS HAPPENED, THE STIMULATOR STOPPED WORKING AND HAD TO BE REMOVED ON (B)(6) 2008. THE LEAD STILL REMAINED IN THE SPINE. THIS INCIDENT CAUSED NEUROLOGICAL DAMAGES, PAIN AND SUFFERING TO THE PT. HE REPORTS THAT HE WAS NEVER EDUCATED OR INFORMED ON THE EFFECTS OF MRI ON THE STIMULATOR AND EVEN AFTER NUMEROUS CONTACTS WITH HIS DR NO WARNING ON THE MRI HAS BEEN GIVEN TO HIM. HE FOUND OUT ABOUT THE EFFECTS BY HIMSELF RESEARCHING ONLINE.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00812301020010	EBI OsteoGen Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020027	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020034	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020041	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020058	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020065	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020072	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020089	SpF XL IIb Implantable Spinal Fusion Stimulator	EBI, LLC	LOE	2014-09-19
00812301020096	SpF®-XL IIb Implantable Spinal Fusion Stimulator	EBI, LLC	LOE	2014-09-19
00812301020102	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020119	EBI OsteoGen™ Implantable Bone Growth Stimulator	EBI, LLC	LOE	2014-09-19
00812301020126	SpF®-PLUS-Mini (60 uA/M)	EBI, LLC	LOE	2014-09-19
00812301020133	SpF®-PLUS-Mini (60 uA/W)	EBI, LLC	LOE	2014-09-19

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P850035S059	LOE	SpF® Implantable Spinal Fusion Stimulators	Ahp Eos Buyer, Inc.	2024-09-20
PMA	P850035S058	LOE	SpF® Implantable Spinal Fusion Stimulators	Ahp Eos Buyer, Inc.	2022-11-23
PMA	P790005S069	LOE	EBI OsteoGen® Implantable Bone Growth Stimulators	Ahp Eos Buyer, Inc.	2022-11-23
PMA	P850035S057	LOE	SpF Implantable Spinal Fusion Stimulators	Ahp Eos Buyer, Inc.	2022-08-25
PMA	P790005S068	LOE	EBI OsteoGen™ Implantable Bone Growth Stimulators	Ahp Eos Buyer, Inc.	2022-08-25

MAUDE MDR 2628891

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

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