MAUDE Adverse Event Report: OSYPKA MEDICAL GMBH MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5391

Device Problem Failure to Sense (1559)

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

Event Date 05/12/2019

Event Type  malfunction  

Manufacturer Narrative

This report is related to initial report from importer oscor with importer report # (b)(4).The device was returned to manufacturer and arrived on (b)(6) 2019.Initial evaluation did not show any functional problem.However, the device showed mechanical damages.The housing was damaged on the arm cuff brackets and lower housing body.Despite the mechanical damages, further evaluation did not raise any function defect causing sensing problems.The failure description could not be reproduced.The pacemaker works according to its specification.Possible causes for sensing failures could be: bad lead to tissue contact.Inappropriate lead position.Not correct adjustment of sensitivity threshold causing undersensing due to wrong sensitivity setting - to hight sensitivity values.Unfortunately there were no further details of the circumstances available which could explain the most likely root cause.After the customer has approved the repair of the damaged housing, the housing part has been replaced and the device has passed safety and functional test and returned to the importer on (b)(6) 2020.

Event Description

It was reported that the external pulse generator (epg) was not sensing.No patient complications have been reported as a result of this event.There was no medical or surgical intervention reported.Time of event is unknown.

• Brand Name: MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): OSYPKA MEDICAL GMBH; albert-einstein-strasse 3; berlin, 12489 ; GM 12489
• Manufacturer (Section G): OSYPKA MEDICAL GMBH; albert-einstein-strasse 3; berlin, 12489 ; GM 12489
• Manufacturer Contact: thilo thuemecke ; albert-einstein-strasse 3; berlin, berlin 12489 ; GM 12489
• MDR Report Key: 9693418
• MDR Text Key: 201883781
• Report Number: 9681449-2020-00003
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: MU
• PMA/PMN Number: K033130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5391
• Device Catalogue Number: 5391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• 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