FDA Adverse Event Malfunction Summary report: N

ACTIVA

MDR report key: 3210041 · Received July 8, 2013

Report

Report Number: 3004209178-2013-11440
Event Type: Malfunction
Date Received: July 8, 2013
Report Date: June 18, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: MHY
PMA / PMN Number: P960009
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT: PRODUCT ID 3387S-40, LOT# V791803, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V791803, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V791803, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V791803, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT HAD HIGH IMPEDANCES AND THEY WERE SEEING THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE ON THE PROGRAMMER. IT WAS STATED THAT THE PATIENT HAD BEEN IMPLANTED "FOR A YEAR". LONGEVITY CALCULATIONS WERE DONE WITH THE PATIENT'S CURRENT SETTINGS AND IT WAS ESTIMATED THAT THE IMPLANT WOULD LAST 9.6 MONTHS.

Description of Event or Problem · 1

IT WAS FURTHER REPORTED THAT THE REVISION WAS SCHEDULED TENTATIVELY FOR 2013 (B)(6). IT WAS FURTHER REPORTED THAT THE DEPLETION WAS SUSPECTED TO BE NORMAL. THE COMPANY REPRESENTATIVE HAD NOT SEEN THE PATIENT, HOWEVER...

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310098	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37601

Patients

Seq	Age	Sex	Outcome	Treatment
1	00017 YR