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

Model Number 5391

Device Problem No Pacing (3268)

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

Event Date 06/13/2019

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 28oct2019.Initial evaluation did not show any functional problem.Only the battery compartment lid was missing.The device underwent 48h long time testing in temperature cycling cabinet.No missing beat has been detected.The evaluation did not raise any function defect causing stimulation problems.The failure description could not be reproduced.The pacemaker works according to its specification.Possible causes for stimulation failures could be: damaged extension or adapter cable (was not returned for evaluation), bad lead to tissue contact, unappropriated lead position, connection problem between lead wire to patient extension cable or extension cable to pacemaker, not correct adjustment of capture threshold due to wrong stimulation amplitude setting.Unfortunately there were no further details of the circumstances available which could explain the most likely root cause.The missing battery compartment lid has been replaced and after calibration and completed safety and functional test returned to the importer on 05dec2019.

Event Description

It was reported that the external pulse generator (epg) did not stimulate.The epg was returned for service.No patient complications have been reported as a result of this event.

• 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, berlin 12489 ; GM 12489
• Manufacturer (Section G): OSYPKA MEDICAL GMBH; albert-einstein-strasse 3; berlin, berlin 12489 ; GM 12489
• Manufacturer Contact: thilo thuemecke ; albert-einstein-strasse 3; berlin, berlin 12489 ; GM 12489
• MDR Report Key: 9503005
• MDR Text Key: 220057590
• Report Number: 9681449-2019-00005
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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: 10/28/2019
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1