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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MYCARELINK PATIENT MONITOR; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC, INC. MYCARELINK PATIENT MONITOR; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number 24950G
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/06/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the remote monitor was hot and has been burning up since yesterday.It was noted that the nurse wrote down all information of the monitor so not to touch the unit.No troubleshooting taken.The monitor is expected to be replaced.No patient complications have been reported as a result of this event.
 
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Brand Name
MYCARELINK PATIENT MONITOR
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key11845314
Report Number2182208-2021-02015
Device Sequence Number3081356
Product Code NVZ
UDI-Device Identifier00643169552104
UDI-Public00643169552104
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 05/18/2021
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 Lay User/Patient
Device Model Number24950G
Device Catalogue Number24950G
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/07/2021
Initial Report FDA Received Date05/18/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age88 YR
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