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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned to manufacturer but was investigated by the distributor service center.The service protocol was provided to the manufacturer on (b)(6) 2022.According to the service report dated (b)(6) 2022: device was received in a good cosmetic condition.Visual check ok.Device was not damaged.Pacemaker worked within specification and passed functional test.It could be confirmed that the pacemaker did not have any defect which could have caused the reported pacing problem.Possible root causes others than the pacemaker would be: contact problems between lead and tissue.Contact problems between lead and patient cable or adapter cable.Defect adapter cable.Inappropriate pacemaker parameter setting (eg.Stimulation amplitude set lower then capture threshold and stimulation was ineffective).

Event Description

It was reported that the external pulse generator (epg) was unable to simulate.The epg is expected to be returned for service.There was no patient complications reported.

• 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: 14187942
• MDR Text Key: 289902021
• Report Number: 9681449-2022-00001
• 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: Other
• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• 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
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1