FDA Adverse Event Malfunction Summary report: N

ACTIVA

MDR report key: 2681641 · Received August 3, 2012

Report

Report Number: 3004209178-2012-06468
Event Type: Malfunction
Date Received: August 3, 2012
Report Date: July 10, 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: AZ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37651, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: 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: PRODUCT ID 3387S-40, LOT# V951526, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V951526, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT WHEN THE PATIENT TURNED HIS DEVICE OFF, HE HAD A BACK ACHE. IT WAS BETTER WITH THE DEVICE BACK ON. THE PATIENT'S DEVICE WAS REPORTED TO BE OFF ONE DAY, BUT HE WAS NOT SURE HOW IT WAS TURNED OFF. THE PATIENT WAS SCHEDULED TO SEE HIS PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. ON (B)(6) 2012 THE DEVICE WAS TURNED BACK ON. THE PATIENT EXPERIENCED BACK PAIN DUE TO THE EVENT. HOSPITALIZATION WAS NOT REQUIRED AND THERE WAS NO PATIENT INJURY.

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