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

Model Number	429524
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
High shock impedance observed on the rv lead.Doctor decided to explant and replace device at same time as lead.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The acticor 7 dr-t df4 promri (sn: 84799019) and the plexa promri s 65 (sn: (b)(6)) under complaint were returned for analysis.The lead solia s 53 (sn: (b)(6)) was not returned for analysis.This report is therefore only based on the analysis of the acticor 7 dr-t df4 promri and the plexa promri s 65 itself as well as the inspection of the quality documents associated with the manufacture of the leads and the icd.The manufacturing process for the devices was re-investigated, revealing that all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance tests proved the devices functions to be as specified.Acticor 7 dr-t df4 promri: upon receipt, the icd was interrogated, revealing the battery status bos.The icd was implanted for 5 months and two charging cycles were recorded to the devices memory.The memory content of the device was inspected.During the analysis of the available iegms noise was observed in the atrial channel as well as in the far field channel.The header of the icd was inspected, revealing no anomalies.In a next step, 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 normal and expected sensing and shock delivery.In particular, the specified energy level was reached.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 atrial channel as well as in the far field channel.However, a thorough analysis of the icd proved the device to be fully functional.There was no indication of a device malfunction.Plexa promri s 65: upon receipt the lead was found cut 11.5 cm distal to the df4 connector pin.A proximal and a distal lead fragment were received for analysis.The performance of the lead fragments was scrutinized, including a visual inspection.The inspection revealed severe abrasion marks at several positions of the lead segments.In particular 9 cm proximal to the insulation was found abraded through and a conductor fracture was observed.This damage is assumed to be the root cause for the clinical observation.Based on the characteristics of the damage, it is reasonable to assume that the lead was subject to severe mechanical stress due to constant friction against another implantable device such as a nearby lead.This assumption could be confirmed during the analysis of the provided fluoroscopic images, where a dislodged atrial lead most likely interacted with the distal part of the shock lead.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• 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: 14515591
• Report Number: 1028232-2022-02757
• Device Sequence Number: 6465787
• 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: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 05/31/2023
• 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: 05/25/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2021
• 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
• Patient Sex: Unknown