FDA Adverse Event Injury Summary report: N

PRIMEADVANCED

MDR report key: 2931660 · Received January 28, 2013

Report

Report Number: 3004209178-2013-01050
Event Type: Injury
Date Received: January 28, 2013
Date of Event: January 9, 2013
Report Date: January 9, 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: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR OFF-LABEL INDICATION. THE INDICATION DEVICE USED FOR WAS MOTOR CORTEX STIMULATION. PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3587A25, LOT # N339611, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3587A25, LOT # N329105, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3587A25, LOT # N329105, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3587A25, LOT # N329105, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PHYSICIAN WAS ACTIVATING A NEW PROGRAM FOR MOTOR CORTEX STIMULATION. WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PROGRAMMED AND AMPLITUDE WAS INCREASED, THE PATIENT HAD A SEIZURE. THE REPORTER INDICATED THAT THE PHYSICIAN WAS GOING TO OBSERVE THE PATIENT FOR A FEW HOURS IN THE EMERGENCY ROOM (ER). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
36772	PRIMEADVANCED	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37702

Patients

Seq	Age	Sex	Outcome	Treatment
1	00054 YR		Other