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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 Contamination (1120)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product analysis: analysis found that the radio frequency programming head failed e-field immunity tests.It was further noted that the magnet was rusty, retainer was cracked, printed circuit board (pcb) had corrosion on it, upper and lower cases had cracked bosses.The device will be scrapped.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the radio frequency programming head received into service with no information and tested out of specification during manufacturer's 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 Key10178238
Report Number2182208-2020-01138
Device Sequence Number2741354
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) 06/22/2020
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 Manufacturer05/20/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/26/2020
Initial Report FDA Received Date06/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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