ACTIVA

MDR report key: 3961336 · Received July 28, 2014

Report

Report Number: 3007566237-2014-02094
Event Type: Malfunction
Date Received: July 28, 2014
Report Date: July 7, 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: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4)

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 37603, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37642, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD ORIGINALLY CALLED BECAUSE THEY COULDN¿T READ THE LEFT INS WITH THE PATIENT PROGRAMMER BUT THEY COULD WITH THE RIGHT INS. THE PATIENT HAD SEEN AN ERROR MESSAGE THAT WAS THE MISTAKEN SHORT CIRCUIT. THE PATIENT HAD HIT A COUPLE OF BUTTONS ON THE PROGRAMMER THAT SOMEHOW CHANGED THE WAY IT READ THE INS. THEY HAD VISITED THEIR PHYSICIAN AND THE CLINICAL PROGRAMMER READ THE LEFT INS WITH NO PROBLEM AND THEY SAW NO ISSUES. NO REPLACEMENT PROCEDURE WAS PERFORMED. THE PATIENT WAS DOING WELL AT THE TIME OF REPORT.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT HAD ISSUES WITH THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS). THE DOCTOR BELIEVED THERE WAS A SHORT IN THE SYSTEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
437980	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37602

Patients

Seq	Age	Sex	Outcome	Treatment
1