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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 Problem Device Damaged by Another Device (2915)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 01/10/2015
Event Type  Injury  
Event Description

It was reported that the programmer was connected to the implanted lead when an external defibrillator had to be used to resuscitate the patient. The programmer "shorted out" and went to the "black screen of death. " another programmer was readily available however the patient was unable to be revived. The programmer was returned for service.

 
Manufacturer Narrative

The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Product event summary: analysis was unable to confirm the customer comment that an automated external defibrillator "shorted out" the programmer. Analysis did find a loose electrocardiogram which was causing common mode wrist test failure. It was noted that due to the nature of the complaint and multiple cosmetic issues the programmer system was to be scrapped. Concomitant product: product id: 229047 software analyzer. (b)(4).

 
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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 Key4675986
MDR Text Key5671453
Report Number2182208-2015-00913
Device Sequence Number1
Product Code KRG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number2090
Device Catalogue Number2090
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/12/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/09/2015 Patient Sequence Number: 1
Treatment
2067 RADIOFREQUENCY PROGRAMMER HEAD
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