MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI S 75; ICD LEAD

Model Number	402267
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this lead was explanted and replaced due to oversensing approx.31 months after the implantation.
Additional Manufacturer Narrative
The lead under complaint was subjected to an extensive analysis.An extraction aid was found on the lead body.The analysis showed multiple abrasion marks along the lead.In particular the insulation in the distal end region was found rubbed through, 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.Further damages such a deformed rv shock coil, most likely resulted from the extraction 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: PLEXA PROMRI S 75
• 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: 13078106
• Report Number: 1028232-2021-06921
• Device Sequence Number: 17644790
• Product Code: NVY
• UDI-Device Identifier: 04035479140038
• UDI-Public: 04035479140038
• Combination Product (Y/N): N
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: 05/31/2020
• Device Model Number: 402267
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2018
• 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