MAUDE Adverse Event Report: OSYPKA MEDICAL GMBH OSYPKA PACE 203H; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number PACE 203H

Device Problem Failure to Sense (1559)

Patient Problem Cardiac Arrest (1762)

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported by the health professional: ventricular sensitivity measured at 7mv.Device set to 3mv.Despite this, after a period of pacing, the device failed to detect three r waves and delivered a pacing spike during repolarisation (t wave), triggering vf.

Manufacturer Narrative

The pacemaker with s/n (b)(6) has been tested first by the uk distribution partner dot medical who found it working as expected with now sign of sensing problems.The device has been forwarded to osypka medical, the manufacturer who received it on 23-feb-2024.The initial functional test did not discover any malfunction except some mechanical damages which are probably not related to the reported incident.Following two long term testing were performed: one 48h monitoring under temperature cycling condition and another 24h continuously sensing monitoring evaluation (using the parameter from the incident).The device has passed all tests without any findings: all parameters worked within its specification.No sensing problem could be observed.The initial reporter has been contacted asking for more ecg readings recorded 30 sec.Before the incident happened.This could not be provided, unfortunately.The root cause of the reported sensing problems could not be identified.If r-on-t pacing happened it could have been caused by the following reasons other than device malfunction: undersensing: sensing problems due to lead connection problems caused pacemaker switched to asynchronous pacing: pacemaker switched to asynchronous pacing due to the presence of interferences.This is a common safety feature on external pacemakers providing misinterpretation of noise signals as intrinsic activities.

• Brand Name: OSYPKA PACE 203H
• 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: mr. joerg ; falkendamm 20a; berlin, berlin 12489 ; GM 12489
• MDR Report Key: 18928256
• MDR Text Key: 337962824
• Report Number: 9681449-2024-00001
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PACE 203H
• Device Catalogue Number: 5I-21-016Z-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 78 KG