MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ETRINSA 8 HF-T; CRT-P

Model Number	394919
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Codes	Syncope (1610); Death (1802); Dizziness (2194)
Date of Event	02/28/2018
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2018 patient presented to the emergency room with syncope, dizziness and hr in the (b)(6).The ekg on arrival showed failure to capture.Patient was given multiple doses of atrophine with no success and externally paced.The cath lab was being prepared with a temporary pacer however patient arrested and coded for an hour.Patient was given epinephrine as well as being intubated.Lab results found patient to be in renal failure with a creatinine of 7.3 and a potassium of 7.0 noted as likely the cause of the patients arrhythmia.Patient received gluconate however was still unresponsive.Patients blood pressure kept decreasing and when they could not feel a pulse, cpr was started and unsuccessful.Patient expired.Physicians final report stated acidosis/hyperkalemia and renal failure as cause of death.The death certificate shows complications of existing medical conditions as cause of death.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.

• Brand Name: ETRINSA 8 HF-T
• Common Device Name: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 7889037
• Report Number: 1028232-2018-03169
• Device Sequence Number: 2726263
• Product Code: NKE
• UDI-Device Identifier: 04035479131777
• UDI-Public: (01)04035479131777
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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: Health Professional
• Device Model Number: 394919
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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: 66 YR