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

Model Number 24950JLQ

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Shock (2072); Electric Shock (2554)

Event Date 10/03/2016

Event Type  malfunction  

Event 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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MYCARELINK
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6162417
• MDR Text Key: 62096296
• Report Number: 3004593495-2016-00524
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169705753
• UDI-Public: 00643169705753
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 24950JLQ
• Device Catalogue Number: 24950JLQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided; 10/03/2016
• Supplement Dates FDA Received: 04/06/2017; 09/27/2017
• Date Device Manufactured: 09/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LNQ11, CARDIAC MONITOR
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR