MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ACTICOR 7 DR-T DF4 PROMRI; ICD

Model Number	429524
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.7 months, oversensing on the ventricular channel was reported.Consultation is now taking place between the physician and patient to explant the whole system for a completely new one.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the battery status bos.The icd was implanted for 12 months and three charging cycles were recorded to the icds memory.The memory content of the device was analyzed.During the analysis of the available iegms noise was observed in the right ventricular channel.Therefore a sensing test was performed, and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be fully functional.There was no indication of a device malfunction.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.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached.The quality documents accompanying the manufacturing processes for these devices were re-investigated.All production steps were performed accordingly, and in particular the final acceptance tests proved the functions of the devices to be as specified.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed in the right ventricular channel.However, a thorough analysis of the icd proved the device to be fully functional.The analysis did not reveal any sign of a material or manufacturing problem of these devices.

• Brand Name: ACTICOR 7 DR-T DF4 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12745690
• Report Number: 1028232-2021-05950
• Device Sequence Number: 14631151
• Product Code: MRM
• UDI-Device Identifier: 04035479156695
• UDI-Public: 04035479156695
• Combination Product (Y/N): N
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 06/30/2022
• Device Model Number: 429524
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2020
• 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
• Patient Sex: Unknown