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

Model Number	24950KLQ
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	08/06/2018
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 that the wand portion of the remote monitor had excessive heating.The doctor stated that the patient had a red mark on the skin from the manual transmission from using the wand.The doctor also stated, first degree burn, no blisters but a red mark that was the exact size of the wand.No intervention was done and patient was not hospitalized.No troubleshooting taken.The monitor is expected to be replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: model: 24950k, serial/lot#: (b)(4): unit was returned without the radio frequency (rf) head.The remote monitor was returned and analysis revealed that no complaint failure was found on the remote monitor ;there was error code 3230 in failure analysis (fa) log.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The monitor was replaced and returned.

• 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: 7809186
• Report Number: 3004593495-2018-00767
• Device Sequence Number: 16527797
• Product Code: NVZ
• UDI-Device Identifier: 00643169725386
• UDI-Public: 00643169725386
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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: 24950KLQ
• Device Catalogue Number: 24950KLQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR