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

Model Number	428768
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
Noise seen on rv channel.Recommended discussing with physician.Device remains implanted.Should additional information be received 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 subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.The insulation was found abraded through 12.5 cm proximal to the lead tip, which is assumed to be the root cause of the reported oversensing.The characteristics of this damage indicate unexpected, excessive wear on the lead.Thus, it is assumed that the lead was subject to severe mechanical stress in the implanted state.Causes for elevated stresses are difficult to determine.An accumulation of different factors may impact wear on the lead.These factors include interaction with atypical tissue, significant cardiac motion due to an adverse lead position including slack, or a potential increased ingrowth which had impact on the manoeuvrability of the lead.Furthermore, tortuous cardiac anatomy, high patient activity levels, and significant manual labour involving the upper body are known contributing factors.Furthermore, a cut into the insulation was found 23.5 cm distal to the df4 connector pin, which probably occurred during the explantation procedure.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: PAMIRA 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: 24572086
• Report Number: 1028232-2026-01238
• Device Sequence Number: 21209152
• Product Code: NVY
• UDI-Device Identifier: 04035479156442
• UDI-Public: (01)04035479156442(17)260331
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2026

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: 03/31/2026
• Device Model Number: 428768
• Device Catalogue Number: 428768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 05/05/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/23/2026; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male