FDA Adverse Event Malfunction Summary report: N

MEDTRONIC INC

MDR report key: 1013088 · Received March 11, 2008

Report

Report Number
MW5005859
Event Type
Malfunction
Date Received
March 11, 2008
Date of Event
March 11, 2008
Report Date
March 11, 2008
Manufacturer
MEDTRONIC, INC
Product Code
FRN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WAS JUST INFORMED TODAY BY MY DR THAT A RECALL WAS ISSUED ON MY INFUSION PUMP FROM MEDTRONIC. THIS RECALL WAS ISSUED IN 2007. I CALLED MEDTRONIC TODAY AND ASKED WHY I WAS NOT NOTIFIED BY MAIL I WAS TOLD, THEY ONLY CONTACT THE DR AND NOT THE PT. WHY THEN DO I HAVE A CARD WITH MY NAME AND ADDRESS ON IT? NEXT, I WAS TOLD THAT THERE IS ONLY A 5% CHANCE OR LESS THAT THE PUMP WOULD FAIL. THEY ONLY OFFERED TO PAY UP TO #1,000.00 IN EXPENSES TO REPLACE THE PUMP. THAT WOULD NOT EVEN COVER THE FACILITY CHARGES LET ALONE THE DR BILL AND MY CO-PAYS. ON TOP OF THAT I SPENT TO FILL THIS DEFECTIVE PUMP. THEY DO NOT WANT TO COVER THAT EXPENSE EITHER. I FELT AFTER THE CONVERSATION WITH MEDTRONIC, I NEEDED TO CONTACT YOU WITH HOW THEY WANT TO HANDLE THIS CLASS I RECALL. MEDTRONIC INFUSION PUMP HAS BEEN REFILLED EVERY 42 DAYS FOR AT LEAST THE PAST TWO YEARS AND NO LESS FREQUENT THAN EVERY 60 DAYS SINCE JANUARY. DATES OF USE: 2001 - 2008. DIAGNOSIS OR REASON FOR USE: PAIN RELIEF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC INC INFUSION PUMP FRN MEDTRONIC, INC 862718

Patients

Seq Age Sex Outcome Treatment
1 56 YR