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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PROGRAMMING HEAD; PROGRAMMER, PACEMAKER
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MEDTRONIC, INC. PROGRAMMING HEAD; PROGRAMMER, PACEMAKER Back to Search Results
Model Number 2067
Medical Device Problem Code Electrical Shorting (2926)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/29/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product analysis: analysis of the radio frequency (rf) programmer head was able to confirm that it was shorting out the programmer.Analysis noted that there was a damaged wire inside of the device, the cable was replaced.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the radiofrequency (rf) head was shorting out the programmer.It was noted that the rf head was recently returned from service and the user was troubleshooting.It was suggested that the issue was the rf head, when the head was removed the programmer booted up.The programmer remains in use.The rf head was returned for service.There was no patient involvement.
 
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Brand Name
PROGRAMMING HEAD
Common Device Name
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key10874576
Report Number2182208-2020-02910
Device Sequence Number3254048
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 Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/20/2020
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 Manufacturer11/02/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/29/2020
Initial Report FDA Received Date11/20/2020
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
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