MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA 7 HF-T DF-1 IS-1 PROMRI; CRT-D

Model Number	404627
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device explanted due to being at eos.No adverse patient events reported.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the eos battery status, 256 charging cycles were recorded in the devices memory.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.The memory content of the device was inspected.During the analysis of the available iegms, noise was observed in the right ventricular channel, leading to multiple charging cycles that partially resulted in shock deliveries.The analysis of the shock holter data showed that an amount of 127 charging cycles were performed by the device between 03:55 am and 08:05 am on december 13, 2021.As a result of that fast-successive charging the eos battery status had occurred.The amount of charge taken from the battery was verified, revealing that the battery condition is as expected.The current consumption was also inspected and found to be normal.There was no indication of a device malfunction.In conclusion, in the available iegms the occurrence of noise was observed in the right ventricular channel.This led to fast successive charging cycles that partially resulted in shock deliveries.The activation of the eos status resulted from that fast-successive charging.However, there was no indication of an icd malfunction.

• Brand Name: INTICA 7 HF-T DF-1 IS-1 PROMRI
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13172814
• Report Number: 1028232-2022-00077
• Device Sequence Number: 17306701
• Product Code: NIK
• UDI-Device Identifier: 04035479142148
• UDI-Public: 04035479142148
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: 11/30/2020
• Device Model Number: 404627
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male