FDA Adverse Event Malfunction Summary report: N

ACTIVA

MDR report key: 3972700 · Received August 1, 2014

Report

Report Number: 3004209178-2014-13799
Event Type: Malfunction
Date Received: August 1, 2014
Report Date: July 13, 2014
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: MHY
PMA / PMN Number: P960009
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 64001, LOT# N240190, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387-40, LOT# V000525, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# V004841, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT PROGRAMMER WAS SHOWING A STRANGE ICON THAT HAD NOT BEEN SEEN BEFORE. IT WAS NOTED AS THE PATIENT WAS CHECKING THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE PATIENT PROGRAMMER THEY SAW ON AND OK AND THEN SAW A ¿CAR BATTERY¿ WITH AN ERROR. THE PATIENT WAS HAVING SYMPTOM CONTROL UNTIL THE MORNING OF THE DATE OF THIS REPORT AT CHURCH ALL OF A SUDDEN THE PATIENT¿S HANDS WERE TREMORING. IT WAS NOTED THAT THE PATIENT WENT HOME AND CHECKED THE IMPLANT. PATIENT TURNED STIMULATION OFF AND TREMORS WERE WORSE. STIMULATION WAS TURNED BACK ON AND IT WAS NOT GREAT BUT IT WAS BETTER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
450920	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37601

Patients

Seq	Age	Sex	Outcome	Treatment
1	00073 YR