MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA S 60; ICD LEAD

Model Number	395722
Medical Device Problem Codes	Mechanical Problem (1384); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this lead had a gradual drop in sensing over time, and then a sudden drop below 2mv in (b)(6) 2020.The lead was capped after the screw was not able to be retracted.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
The previously capped lead was explanted on (b)(6) 2024.The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Additional Manufacturer Narrative
The previously capped lead was explanted on (b)(6) 2024 upon receipt, the lead under complaint was found cut 11.5 cm distal to the df4 connector pin into two segments.An extraction aid was found on the distal fragment, it is reasonable to assume that the lead was cut during the surgery.The insulation was, apart from the present cut, free of injuries.The ring electrode and rv shock coil were found covered in fibrotic growth.The calcification might have led to electrical issues.The fixation helix was found stretched, which most likely occurred during the extraction procedure due to tensile stress.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 S 60
• 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: 11297991
• Report Number: 1028232-2021-00685
• Device Sequence Number: 10944804
• Product Code: NVY
• UDI-Device Identifier: 04035479133139
• UDI-Public: (01)04035479133139(17)211031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/21/2024

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: 10/31/2021
• Device Model Number: 395722
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/06/2021
• Supplement Date Received by Manufacturer: 02/15/2021; 01/18/2024; 06/21/2024
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 02/16/2021; 01/23/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2019
• 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
• Patient Age: 45 YR
• Patient Sex: Female