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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC CARELINK MONITOR (PATIENT HOME MONITOR); PULSE GENERATOR, PERMANENT, IMPLANTABLE
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MEDTRONIC, INC. MEDTRONIC CARELINK MONITOR (PATIENT HOME MONITOR); PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number 2490H10
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/22/2021
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 old batteries leaked and caused damage to the coils.Troubleshooting steps were taken to no avail.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
MEDTRONIC CARELINK MONITOR (PATIENT HOME MONITOR)
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key12713588
Report Number2182208-2021-04265
Device Sequence Number11899809
Product Code NVZ
UDI-Device Identifier00643169341074
UDI-Public00643169341074
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 consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/28/2021
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 Number2490H10
Device Catalogue Number2490H10
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/22/2021
Initial Report FDA Received Date10/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age81 YR
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