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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 2067L
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/07/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product analysis: analysis was able to confirm the customer comment that there was a short in the cable of the radiofrequency (rf) head and it was noted that the rf head was unable to interrogate.It was noted that the rf head failed uplink/e-immunity tests.The rf head passed tests and interrogated with a known good cable.The rf head is no longer needed and will be scrapped.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that there was a "short" in the cable of the radiofrequency (rf) head.No patient complications have been reported as a result of this event.
 
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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 Key12727155
Report Number2182208-2021-04284
Device Sequence Number16504092
Product Code KRG
UDI-Device Identifier00613994435125
UDI-Public00613994435125
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) 11/01/2021
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 Manufacturer10/07/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/07/2021
Initial Report FDA Received Date11/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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