FDA Adverse Event Injury Summary report: N

RESTORE PRIME

MDR report key: 3467149 · Received November 13, 2013

Report

Report Number: 3004209178-2013-20722
Event Type: Injury
Date Received: November 13, 2013
Report Date: October 21, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3093-28 LOT# V800435, IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3093-28 LOT# V800435, IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-28 LOT# J0555535V, IMPLANTED: 2005 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-28 LOT# J0555535V, IMPLANTED: 2005 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE EXTENSION (B)(4). THE DEVICE WAS USED FOR AN OFF LABEL INDICATION.

Description of Event or Problem · 1

IT WAS REPORTED, THE PATIENT ¿ONLY HAD HIS IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED AND IT DIDN¿T WORK, AND THEY ALSO TOOK OUT THE WIRES BUT HE STILL HAD HIS INS IMPLANTED.¿ REPORTEDLY, THE LEADS WERE REMOVED SEVERAL MONTHS AGO. IT WAS STATED ONE DOCTOR ¿SCREWED UP THE SURGERY AND ANOTHER DOCTOR WENT IN AND FIXED IT¿ IN 2011. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
587086	RESTORE PRIME	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37701

Patients

Seq	Age	Sex	Outcome	Treatment
1	00070 YR		Required Intervention