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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD MYCARELINK; PULSE GENERATOR, PERMANENT, IMPLANTABLE
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PLEXUS MANUFACTURING SDN. BHD MYCARELINK; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number 24950JLQ
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/07/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the remote monitor reader was getting too hot to touch.That patient was asked if it was warmer than normal electronics would get and the patient responded yes.The patient was advised to disconnect for at least 20 minutes and give it time to cool down and call back if the issue continues.The monitor is still in use.No patient complications have been reported as a result of this event.
 
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Brand Name
MYCARELINK
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
PLEXUS MANUFACTURING SDN. BHD
bayan lepas free industrial zo
bayan lepas 11900
MY  11900
MDR Report Key6923293
Report Number3004593495-2017-00563
Device Sequence Number852157
Product Code NVZ
UDI-Device Identifier00643169705753
UDI-Public00643169705753
Combination Product (Y/N)N
Initial Reporter StateCA
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 Other
Type of Report Initial
Report Date (Section B) 08/07/2017
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 Number24950JLQ
Device Catalogue Number24950JLQ
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/07/2017
Initial Report FDA Received Date10/06/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age79 YR
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