MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK ENCORE; PROGRAMMER, PACEMAKER

Model Number 29901

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the programmer was smoking and smelled burnt; the programmer cord was melted where it plugged into the programmer.The programmer is expected to be returned.There was no patient involvement.

Manufacturer Narrative

Product analysis: manufacturer's analysis confirmed the customer comment that the programmer power supply cord and connector were damaged.It was not confirm that the programmer was smoking and smelled burnt.The programmer was repaired and returned to service.If information is provided in the future, a supplemental report will be issued.

Event Description

The programmer was returned for service.

Manufacturer Narrative

Failure analysis was performed on the power supply.Visual inspection: power connector has melted plastic around the metal plug.Benchtop analysis: checked electrically connection between the +19v output and ground ¿ electrical short.Confirmed customer complaint caused by power supply connector failure.The dc plug cable end is electrically shorted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK ENCORE
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 7839135
• MDR Text Key: 119028822
• Report Number: 3004593495-2018-00822
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00643169369030
• UDI-Public: 00643169369030
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2018

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
• Device Operator: Other
• Device Model Number: 29901
• Device Catalogue Number: 29901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 09/10/2018; 10/12/2018
• Supplement Dates FDA Received: 09/11/2018; 10/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• 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