MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD MYCARELINK; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	24950E
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	02/01/2018
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 by the clinician that the patient saw the monitor blinking, held the wand over the device to do a full report, but the device began to feel hot and skin turned red.The patient stopped placing the monitor reader over the device and no further reaction.The monitor is expected to be replaced.No patient complications have been reported as a result of this event.

• 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 Key: 7415771
• Report Number: 3004593495-2018-00216
• Device Sequence Number: 16459700
• Product Code: NVZ
• UDI-Device Identifier: 00643169452060
• UDI-Public: 00643169452060
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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 Number: 24950E
• Device Catalogue Number: 24950E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR