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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK PROGRAMMER, PACEMAKER

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MEDTRONIC, INC. CARELINK PROGRAMMER, PACEMAKER Back to Search Results
Model Number 2090
Device Problems Communication or Transmission Problem (2896); Programming Issue (3014)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 11/18/2015
Event Type  Malfunction  
Manufacturer Narrative

This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. The exact serial number of the programmer used during the event is not known definitely but was either (b)(4). (b)(4).

 
Event Description

It was reported that the patient is deceased. It was further reported the patient experienced asystole the during the night following their device implant procedure. Resuscitation efforts were initiated. Forty minutes into the resuscitation effort, the programmer was utilized to interrogate and reprogram the device. The device was unable to be interrogated. The programmer displayed question marks in the programmable fields and the values were unable to be modified. After an additional fifty minutes of resuscitation efforts, the programmer was then used to successfully to reprogram the device to the emergency vvi mode. The programmer remains in use. Resuscitation efforts of the patient were ultimately unsuccessful. The patient's death was not related to the use of the programmer.

 
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Brand NameCARELINK
Type of DevicePROGRAMMER, PACEMAKER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key5420902
MDR Text Key38379369
Report Number2182208-2016-00090
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberP890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number2090
Device Catalogue Number2090
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/01/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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