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

Model Number	429524
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/15/2021
Type of Reportable Event	Death
Event or Problem Description
After an implantation period of approx.19 months, it was reported that the interrogation of the device was not successful.The patient died six days after the incident and the icd was explanted.
Additional Manufacturer Narrative
The icd was visually inspected.The inspection revealed signs of an electrical arc-over on the icd housing as well as on the icd antenna inside the header.This indicates shock delivery into an external short circuit between icd case and antenna.Subsequently, the icd was subjected to an electrical analysis.Thereby the device could not be interrogated, and the therapy functionality was not available.The icd was opened to inspect the inner assembly.A damage of the electronic module was identified, in particular, the fuse separating the battery from the electronic module was blown.The evidence suggests that the fuse was blown by an external short circuit.This has caused the lack of interrogation and therapy functionality.The header of the icd was inspected in detail and identified the root cause of the external short circuit to be a misaligned placement of the telemetry antenna.Every manufactured icd undergoes a multitude of electrical, visual and mechanical tests and inspections before it is shipped.Furthermore, at the last step of the manufacturing process, a visual and electrical final acceptance test is performed.This particular device passed this test successfully and all device functions proved to be as specified.As a result of this event, processes have been reviewed and relevant staff has been re-educated and retrained.In accordance to biotroniks post-market surveillance system this occurrence represents an extremely rare event.

• 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: 12913951
• Report Number: 1028232-2021-06465
• Device Sequence Number: 4740055
• 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): 11/23/2021

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 Expiration Date: 01/31/2022
• Device Model Number: 429524
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown