FDA Adverse Event Malfunction Summary report: N

ACTIVA

MDR report key: 2840831 · Received November 20, 2012

Report

Report Number: 3004209178-2012-10589
Event Type: Malfunction
Date Received: November 20, 2012
Report Date: October 24, 2012
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: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 7495-51, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID 3387-40, LOT# J0101957V. PRODUCT TYPE: LEAD: PRODUCT ID 3387-40, LOT# L84432. PRODUCT TYPE: LEAD. (B)(4).

Description of Event or Problem · 1

FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED, THE CAUSE OF THE EVENT WAS UNKNOWN. ALL IMPEDANCES WERE NORMAL. REPROGRAMMING WAS DONE ON (B)(6) 2012 NO ELECTRODES OUT OF RANGE, IMPEDANCES WERE "OK." PATIENT DESCRIBED LEFT NECK SENSATION. IT WAS ALSO NOTED, THE PATIENT WOULD BE EXAMINED FOR POSSIBLE NECK SPASM. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION WAS REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT WAS "ZAPPED" WHEN TRYING TO TURN BOTH IMPLANTABLE NEUROSTIMULATORS (INS) OFF FOR AN ELECTROCARDIOGRAM (ECG) PROCEDURE. THE LEFT SIDE WAS OFF BUT THE RIGHT SIDE WAS IN ICON MODE AND SHOWED A FLASHING WARNING SIGN. THE PATIENT RECEIVED THE UNWANTED SHOCK WHILE TURNING THE RIGHT SIDE OFF. IT WAS NOTED THE PATIENT HAD ECG PROCEDURES I THE PAST AND THERE WAS NO INTERFERENCE. THIS WAS THE FIRST OCCURRENCE OF INTERFERENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37612

Patients

Seq	Age	Sex	Outcome	Treatment
1