MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK ENCORE; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number 29901

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2015

Event Type  malfunction  

Event Description

It was reported the programmer would not stay powered on.The power cord and battery were replaced, but the issue was not resolved; it worked for two days.The programmer was returned for repair.No patient involvement or complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product event summary: analysis found that the programmer would not power up.However the device powered up and stayed powered up with a known good battery.

Manufacturer Narrative

Product event summary: analysis found that the programmer would not power up.Visual inspection revealed no anomalies.Bench analysis revealed the programmer would not power on.The programmer was disassembled and inspected.The board that interfaces between the external power supply and the programmer was inspected and an unsoldered component was found.The solder was touched up and the programmer was reassembled.The programmer then powered on with no issues and was able to charge the battery.It was also noted during disassembly that several screw bosses were cracked in the handle assembly.Conclusion: reported event was confirmed.The programmer had a solder defect in the power supply interface.

Manufacturer Narrative

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

• Brand Name: CARELINK ENCORE
• Type of Device: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4678832
• MDR Text Key: 5672081
• Report Number: 3004593495-2015-00050
• Device Sequence Number: 1
• Product Code: OSR
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/04/2015

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: Health Professional
• Device Model Number: 29901
• Device Catalogue Number: 29901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 04/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 05/27/2015
• Supplement Dates FDA Received: 06/10/2015; 08/04/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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
• Treatment: 26901 RF (RADIO-FREQUENCY) HEAD