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

Model Number	24950J
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock (2072)
Date of Event	09/06/2016
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the patient was shocked by the remote monitor during the interrogation phase of a remote transmission.The patient was assured that the monitor does not perform therapy to implanted device but collects and sends transmissions.The patient was referred to the clinic to have implanted device and monitor checked.A follow up call was made to the clinic.The nurse stated that the patient had been seen in clinic twice since the call for a device check and follow up and everything was within normal limits.Both the monitor and the implanted device remain in use.No further patient complications have been reported as a result of this event.
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: 6160739
• Report Number: 3004593495-2016-00492
• Device Sequence Number: 928731
• Product Code: NVZ
• UDI-Device Identifier: 00643169657885
• UDI-Public: 00643169657885
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/06/2016

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: 24950J
• Device Catalogue Number: 24950J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2016
• Supplement Date Received by Manufacturer: Not provided; 09/06/2016
• 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: DDMB1D4, ICD, 5076, 6947, LEADS
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 49 YR