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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 2067L
Medical Device Problem Code Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 08/10/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product analysis: analysis found that the radiofrequency head had an out of specification printed circuit board (pcb) assembly.When the head was connected to the programmer, it would cause a programmer shutdown.The unit also failed testing and was unable to interrogate.The head has been scrapped and replaced.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The radiofrequency (rf) head that was returned after being dropped subsequently tested out of specification during manufacturer's analysis.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 Key7840510
Report Number2182208-2018-01602
Device Sequence Number1129813
Product Code KRG
UDI-Device Identifier00721902290138
UDI-Public00721902290138
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 Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/01/2018
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 Number2067L
Device Catalogue Number2067L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2018
Initial Report FDA Received Date09/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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