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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 No Device Output (1435)
Patient Problem No Patient Involvement (2645)
Event Date 05/13/2015
Event Type  malfunction  
Manufacturer Narrative
This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: during analysis it was noted that the programmer had a worn lower case and a loose electrocardiogram connector on the link electronic module (lem), both were replaced and additionally the lem was calibrated, and that the software was reconfigured, reloaded and updated software.(b)(4).
 
Event Description
The programmer was returned with no information and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.
 
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Brand Name
CARELINK
Type of Device
PROGRAMMER, 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 Key4969175
MDR Text Key22503001
Report Number2182208-2015-02603
Device Sequence Number1
Product Code KRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Report Date 06/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2090
Device Catalogue Number2090
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/05/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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