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

Model Number	24950JLQ
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Shock (2072); Electric Shock (2554)
Date of Event	10/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had questions about how to work the hand held activator and was shocked by the remote monitor when the reader was placed against the device.The patient was advised to contact the clinic and educated that the monitor and device do not have any type of shock therapy that it provides to the patient.The monitor and device are still in use and the patient has had several successful transmissions since the date of the call.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6162417
• Report Number: 3004593495-2016-00524
• Device Sequence Number: 16259463
• Product Code: NVZ
• UDI-Device Identifier: 00643169705753
• UDI-Public: 00643169705753
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 24950JLQ
• Device Catalogue Number: 24950JLQ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2016
• Supplement Date Received by Manufacturer: Not provided; 10/03/2016
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 04/06/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LNQ11, CARDIAC MONITOR
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 53 YR