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

Model Number	394919
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
This device was explanted and replaced due to eri from lv lead with high thresholds and is programmed to 6.5v at 1.0ms.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.
Additional Manufacturer Narrative
The pacemaker was returned and analyzed.The memory content demonstrated a normal functionality of the device while implanted and in service.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.There was no indication of a device malfunction.The device interrogation revealed the battery status - ok - with 20 percent remaining battery capacity.The archive data and the programmed parameters were inspected.High left ventricular pacing outputs of 6.5v and 1.0ms were documented in the archive data.This represents a high current program, which results in a faster discharge of the battery.The amount of charge taken from the battery was verified and the battery condition was found to be as expected.In conclusion, the pacemaker was fully functional.The battery condition was anticipated.

• Brand Name: ETRINSA 8 HF-T
• Common Device Name: CRT-P
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9187387
• Report Number: 1028232-2019-04451
• Device Sequence Number: 2323142
• Product Code: NKE
• UDI-Device Identifier: 04035479131777
• UDI-Public: 04035479131777
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 394919
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/18/2019; 01/23/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 10/22/2019; 01/29/2020
• 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: Hospitalization
• Patient Age: 88 YR