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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 2067
Device Problems Contamination (1120); Degraded (1153)
Patient Problem No Patient Involvement (2645)
Event Date 10/07/2016
Event Type  malfunction  
Manufacturer Narrative
Product event summary: it was found that the radiofrequency head was broken and internally contaminated.
 
Event Description
The radiofrequency (rf) programmer head that was returned with no information 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, 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 Key6162638
MDR Text Key62222503
Report Number2182208-2016-02787
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
Type of Report Initial
Report Date 10/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2067
Device Catalogue Number2067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received10/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2004
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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