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

Model Number	5391
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Cardiogenic Shock (2262)
Date of Event	06/09/2015
Type of Reportable Event	Death
Event or Problem Description
It was reported the patient went into asystole when the pacing cables on the external pulse generator (epg) "popped out" after they were secured into the device.It was determined the prongs were not completely tightened and the cables slid out.Troubleshooting showed the prongs came loose.Follow up revealed the temporary lead was placed in the intensive care/cardiac care unit when the patient went into shock.The patient was transferred to the catharization lab for permanent placement and when the patient was moved the lead "popped out." the patient went into asystole and there was electro-mechanical dissociation.The lead was then tightened down, cardio-pulmonary resuscitation was started and the patient expired 45 minutes to one hour later.The status of the epg is not known at this time.Additional information was subsequently received from the physician that the primary cause of death is believed to be lactic acidosis and secondary bradycardia.Follow-up requests for further information were unsuccessful.

• Brand Name: MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER
• Common Device Name: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): OSYPKA MEDICAL GMBH; albert-einstein-strasse 3; berlin, 12489 ; GM 12489
• MDR Report Key: 7036844
• Report Number: 1035166-2017-00099
• Device Sequence Number: 1013609
• Product Code: DTE
• UDI-Device Identifier: 00643169382978
• UDI-Public: 00643169382978
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2017
• Report Date (Section F): 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 5391
• Device Catalogue Number: 5391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/21/2016
• Device Age: 1 YR
• Date Report to Manufacturer: 07/08/2015
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Date Report Sent to FDA: 07/09/2015