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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
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/09/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product analysis: the rf head cable was found to be out of electrical specification.Specifically, when connected to the programmer, it prevented the programmer from powering on, and when connected to a powered programmer, the rf head would cause the programmer to shut off.The rf head cable was replaced.The rf head passed all final functional testing.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The radio frequency (rf) programmer head was returned as an associated product and subsequently tested out of specification.There was no patient involvement.
 
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Brand Name
CARELINK
Common Device Name
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key7518553
Report Number2182208-2018-00917
Device Sequence Number1529462
Product Code KRG
UDI-Device Identifier00721902290121
UDI-Public00721902290121
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/16/2018
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
Operator of Device Other
Device Model Number2067
Device Catalogue Number2067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/23/2018
Initial Report FDA Received Date05/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
2090 PROGRAMMER, 2290 ANALYZER
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