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

Model Number 394919

Device Problem Failure to Capture (1081)

Patient Problems Syncope (1610); Death (1802); Dizziness (2194)

Event Date 02/28/2018

Event Type  Death  

Event 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.

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
• Type of Device: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 7889037
• MDR Text Key: 120714961
• Report Number: 1028232-2018-03169
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 04035479131777
• UDI-Public: (01)04035479131777
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 394919
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR