FDA Adverse Event Malfunction Summary report: N

UNKNOWN

MDR report key: 21168740 · Received January 16, 2025

Report

Report Number: 9681449-2025-00002
Event Type: Malfunction
Date Received: January 16, 2025
Date of Event: September 24, 2024
Report Date: January 16, 2025
Manufacturer: OSYPKA MEDICAL GMBH
Product Code: DTE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE MDR REPORT# MW5163637 DID NOT PROVIDE ENOUGH INFORMATION TO IDENTIFY THE MODEL WHICH WOULD HAVE BEEN INVOLVED IN THE REPORTED EVENT. SINCE THERE WAS NO INFORMATION ABOUT THE REPORTER OR DETAILS ABOUT THE HOSPTIAL THERE WAS NO CHANCE TO DO ANY FURTHER INVESTIGATION. OBVIOUSLY, THE REPORTER IS NOT AVAILABLE TO GIVE MORE DETAILS ABOUT THE DEVICE (MODEL, SN). THERE ARE CERTAIN DOUBTS THAT THIS INCIDENT IS ACTUALLY RELATED TO AN EXTERNAL PACEMAKER AT ALL. THE WORD: "ABLATION."LEADS TO CONJECTURE THAT THE REPORTER IS REFERRING ACTUALLY TO A RF ABLATION GENERATOR WITH ABLATION CATHETER. OSYPKA MEDICAL GMBH IS NOT MANUFACTURING SUCH DEVICES.

Description of Event or Problem · 0

MANUFACTURER RECEIVED VOLUNTARY AND ANONYMOUS MDR REPORT# MW5163637: ABLATION WITH THE OSYPKA GENERATOR DID NOT WORK. A NEW ADAPTOR FOR OSYPKA IS ORDERED BY THE CUSTOMER. THEY USED ANOTHER CATHETER FROM ANOTHER COMPANY TO COMPLETE THE PROCEDURE CONVENTIONALLY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). ACCORDING TO THE MDR REPORT AN EXTERNAL PACEMAKER WAS INVOLVED BUT NO MODEL NAME OR SERIAL NUMBER WAS PROVIDED AND THE REPORTED EVENT LEAD TO A HIGH FREQUENT ABLATION GENERATOR AND RELATED ABLATION CATHETER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1953979	UNKNOWN	PULSE-GENERATOR, PACEMAKER, EXTERNAL	DTE	OSYPKA MEDICAL GMBH	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other