FDA Adverse Event Injury Summary report: N

MEDTRONIC

MDR report key: 1060654 · Received June 10, 2008

Report

Report Number
MW5007287
Event Type
Injury
Date Received
June 10, 2008
Date of Event
June 2, 2008
Report Date
June 10, 2008
Manufacturer
MEDTRONIC INC.
Product Code
DTE
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IN, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

UPON PHYSICIAN EXAMINING THE PATIENT AT 0700, THE PACEMAKER WAS FOUND TO BE SHUT OFF. THE PHYSICIAN DISCUSSED PACEMAKER BEING OFF WITH THE NIGHT SHIFT NURSE AND THEY BOTH DETERMINED THAT THERE WAS NO REASON FOR THE UNIT BEING OFF. THE PACEMAKER WAS TURNED BACK ON AND WAS NOTED AS FUNCTIONING PROPERLY. THE DAY SHIFT NURSE NOTICED LATER IN THE DAY THAT THE PATIENT'S ECG WAVEFORM DID NOT HAVE THE EXPECTED PACEMAKER SPIKES. SHE CHECKED THE PACEMAKER AND FOUND IT TO BE SHUT OFF. SHE REPLACED THE BATTERY AND NOTED THE UNIT WAS FUNCTIONING PROPERLY. SHE ALSO NOTED THAT THE PATIENT REMAINED STABLE THROUGHOUT THE ESTIMATED 15 MINUTES THAT THE UNIT WAS OFF. IN 2008, A NURSE FOUND THE PACEMAKER WAS FOUND TO BE TURNED OFF AND ESTIMATED THAT IT HAD BEEN OFF FOR APPROXIMATELY ONE HOUR. THE PHYSICIAN WAS NOTIFIED AND THE PACEMAKER WAS CHANGED OUT WITH ANOTHER UNIT. THE NURSE NOTED THAT THE PATIENT WAS STABLE THROUGHOUT THE EVENT. THE PATIENT'S CHART SHOWS THAT USE OF THE PACEMAKER WAS DISCONTINUED LATER ON IN THE AFTERNOON BUT NOT DISCONNECTED UNTIL ABOUT 2 DAYS LATER. THE AFFECTED UNIT WAS SENT TO CLINICAL ENGINEERING FOR EVALUATION. UPON EVALUATION, THE UNIT WAS RAN THREE SEPARATE TIMES WITH NEW BATTERIES AND THE UNIT FAILED TO OPERATE MORE THAN TWENTY FOUR HOURS. MFG SPECS INDICATE THAT THE UNIT SHOULD RUN APPROXIMATELY SEVEN TO NINE DAYS ON A NEW BATTERY. OUR OTHER UNITS OF THE SAME MODEL NUMBER ARE CURRENTLY BEING EVALUATED AND SO FAR ARE FOLLOWING MFG SPECS. THE PATIENT WAS RELEASED ON THE DAY THE DEVICE WAS DISCONNECTED WITH NO NOTED EFFECTS FROM THE PACEMAKER PROBLEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC DUAL CHAMBER TEMPORARY PACEMAKER DTE MEDTRONIC INC. 5388

Patients

Seq Age Sex Outcome Treatment
1 69 YR Life Threatening