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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 Inadequate User Interface (2958)
Patient Problems Syncope (1610); Cardiac Arrest (1762); Seizures (2063)
Event Date 07/31/2017
Event Type  Injury  
Event Description

It was reported that the patient experienced transient asystole, syncope and a seizure when the programmer wand was placed over the device during a device check. The implantable pulse generator (ipg) was at end of life (eol) and was unable to be interrogated. When the wand was placed over the device, the device exhibited no pacing and experienced a loss of output. It was noted this occurred twice. A temporary pacing wire was then placed until the the implantable pulse generator (ipg) was explanted and replaced the following day. The programmer remains in use. No further patient complications have been reported as a result of this event.

 
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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, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6930641
MDR Text Key88850771
Report Number2182208-2017-01767
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
Reporter Occupation
Type of Report Initial
Report Date 07/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
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 Received07/31/2017
Was Device Evaluated By Manufacturer? No Answer Provided
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: 10/09/2017 Patient Sequence Number: 1
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