MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI S DX 65/17; ICD LEAD

Model Number	436910
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
This lead was explanted due to shock impedance out of range.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Combination product: yes.The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
Combination product: yes.Upon receipt, the lead under complaint was found cut 13.5 cm distal to the is-1 connector pin and 11 cm proximal to the lead tip.The proximal and distal fragments were received for analysis.The medial fragment was not returned.An extraction aid was found on the distal fragment; it is reasonable to assume that the lead was cut during the surgery.The returned lead fragments were analyzed.The inspection revealed that the insulation was, apart from the present cut, free of breaches.During the electrical analysis, the dc resistances of the received conductor fragments were measured.No peculiarities were found.Further analysis of the returned lead fragments did not reveal any irregularity that might have contributed to the reported clinical observation.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: PLEXA PROMRI S DX 65/17
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 24249121
• Report Number: 1028232-2026-00594
• Device Sequence Number: 9593549
• Product Code: NVY
• UDI-Device Identifier: 04035479158798
• UDI-Public: (01)04035479158798(17)230630
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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: 06/30/2023
• Device Model Number: 436910
• Device Catalogue Number: 436910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 02/04/2026; 04/08/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/04/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male