FDA Adverse Event Malfunction Summary report: N

ACTIVA

MDR report key: 2842690 · Received November 21, 2012

Report

Report Number: 3004209178-2012-10654
Event Type: Malfunction
Date Received: November 21, 2012
Report Date: October 25, 2012
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

PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 2001-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2002-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387-40, LOT# J0101918V, IMPLANTED: 2001-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387-40, LOT# J0120572V, IMPLANTED: 2002-(B)(6), PRODUCT TYPE LEAD. (B)(4).

Description of Event or Problem · 1

A COMPLAINT WAS REPORTED THAT THE IMPEDANCE ON CONTACT 3 WAS GREATER THAN 40K WHICH OCCURRED AFTER THE INS (IMPLANTABLE NEUROSTIMULATOR) REPLACEMENT. THE PATIENT WAS REPROGRAMMED. IT WAS MENTIONED THAT THE PATIENT HAD NOT HAD THERAPY ON 'THIS SIDE' SINCE REVISION BUT IT IS UNCLEAR ON WHICH SIDE THE PATIENT WAS HAVING THE ISSUE. PATIENT HAD GOOD THERAPY AND GOOD IMPEDANCES BEFORE THE SURGERY. THE IMPEDANCES WERE NOT CHECKED "INTER-OP." PATIENT FELT A 'SURGE' DURING THE IMPEDANCE TEST. ADDITIONAL INFORMATION RECEIVED SHOWED THAT THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP WITH THE PHYSICIAN BUT NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. SEE MANUFACTURING REPORT NUMBER 3004209178-2012-10650. BILATERAL SYSTEM AND IS UNCLEAR WHICH SYSTEM PROBLEM PERTAINS TO. THEREFORE, MDR FILED ON BOTH.

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	37602

Patients

Seq	Age	Sex	Outcome	Treatment
1