MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO SD 60/16; ICD LEAD

Model Number	399408
Medical Device Problem Code	Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Lead was explanted due to noise after car accident with seatbelt on.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was cut 51 cm proximal to the lead tip.Only the distal lead fragment with inserted locking stylet was returned and subjected to an extensive analysis.In the course of the analysis, multiple signs of wear could be noted on the proximal part of the lead fragment.In particular 12.8 cm proximal to the lead tip the insulation was found rubbed through which can be considered the root cause for 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 maneuverability of the lead.Furthermore, tortuous cardiac anatomy, high patient activity levels, and significant manual labor involving the upper body are known contributing factors.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: PROTEGO SD 60/16
• 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: 18307394
• Report Number: 1028232-2023-06222
• Device Sequence Number: 20529154
• Product Code: NVY
• UDI-Device Identifier: 04035479136093
• UDI-Public: (01)04035479136093(17)160930
• 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: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 09/30/2016
• Device Model Number: 399408
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2014
• 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: 75 YR
• Patient Sex: Male