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

Model Number	2020B2
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/14/2019
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 batteries inside the monitor exploded.The monitor was compromised and was no longer usable.No troubleshooting indicated.The monitor is expected to be replaced.There was no patient involvement.

• Brand Name: CARELINK EXPRESS MONITOR
• 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: 9231406
• Report Number: 3004593495-2019-01116
• Device Sequence Number: 19453944
• Product Code: NVZ
• UDI-Device Identifier: 00643169107052
• UDI-Public: 00643169107052
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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: Health Professional
• Device Model Number: 2020B2
• Device Catalogue Number: 2020B2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1