MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI DF-1 S 65; ICD LEAD

Model Number	413997
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Syncope/Fainting (4411)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This rv lead was explanted after failed attempt to reposition lead due to helix would not retract.Patient had had a syncopal episode and vf with failed icd shock, and during (b)(6) 2024 ep visit for cardioversion, dft resulted in three failed shocks.Should additional information be received, this file will be updated.
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.A cut into the insulation was found 36.5 cm distal to the is-1 connector pin, blood penetrated the lead in this region.The cut probably occurred during the surgery.Furthermore, the inner coil was found fractured and overrotated 2.5 cm distal to the is-1 connector pin.The damage most likely occurred during the extension or retraction of the fixation helix.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 DF-1 S 65
• 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: 19577102
• Report Number: 1028232-2024-03336
• Device Sequence Number: 8409809
• Product Code: NVY
• UDI-Device Identifier: 04035479150969
• UDI-Public: (01)04035479150969(17)251231
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 413997
• Device Catalogue Number: 413997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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: 63 YR
• Patient Sex: Male