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

Model Number 5391

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2016

Event Type  malfunction  

Event Description

The customer reported that the external pulse generator (epg) would not stimulate.The device was not in patient use at the time of this event.Additional information has been requested but not received to date.The device has not been received for evaluation.

• 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 Contact: thilo thuemecke ; albert-einstein-strasse 3; berlin, berlin 12489 ; GM 12489 ; 9306392833
• MDR Report Key: 5952069
• MDR Text Key: 54754344
• Report Number: 9681449-2016-00003
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1