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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 Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/22/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product analysis :it was determined at analysis that the radiofrequency head failed e-field immunity tests.It was further noted that corrosion was found inside the device when opened.The device will be scrapped and replaced.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The radiofrequency head was returned as an associate device subsequently tested out of specification during manufacturers analysis.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 Key10430007
Report Number2182208-2020-01573
Device Sequence Number11360889
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) 08/20/2020
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 Number2067L
Device Catalogue Number2067L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/22/2020
Initial Report FDA Received Date08/20/2020
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,229047 ANALYZER.
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