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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 Connection Problem (2900)
Patient Problem Infection, Indirect (2245)
Event Date 07/25/2018
Event Type  Malfunction  
Manufacturer Narrative

Product analysis: manufacturer's analysis indicated that the programmer had a deviation between the stylus and the cursor on the screen. It was indicated that the touchscreen connector required cleaning and reseating. The programmer was repaired and returned to service. This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action. The device is no longer included as part of the field action. If information is provided in the future, a supplemental report will be issued.

 
Event Description

The programmer was returned and subsequently tested out of specification during manufacturer's analysis. There was no patient involvement.

 
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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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8245871
MDR Text Key133047811
Report Number2182208-2019-00099
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 01/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/14/2019
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 Manufacturer12/21/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/31/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0406-2019

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