MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 53401

Device Problems Device Difficult to Program or Calibrate (1496); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2018

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 external pulse generator had been programmed to a low, back-up rate but it suddenly and without interaction reverted to standard pacing settings of 80 beats-per-minute and 10 milliamperes.The generator was reprogrammed.It has not been received into service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: the stated reason for return was not confirmed.The device passed all tests with no visual or electrical anomalies.The firmware was updated as per advisory instructions.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.

Event Description

The product was returned to service.

Manufacturer Narrative

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.

Manufacturer Narrative

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

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• 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: 7411707
• MDR Text Key: 105283756
• Report Number: 3004593495-2018-00144
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K162054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/14/2018

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: Health Professional
• Device Model Number: 53401
• Device Catalogue Number: 53401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 01/06/2018; 05/24/2018; 08/10/2018; 08/20/2018
• Supplement Dates FDA Received: 05/24/2018; 06/04/2018; 08/10/2018; 09/14/2018
• Date Device Manufactured: 04/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2317-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention