BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 22916107 · Received August 28, 2025

    Report

    Report Number
    2649622-2025-23629
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 28, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. CONTINUATION OF D10: 3608 LEAD IMPLANTED: (B)(6) 2015, 360883 LEAD IMPLANTED: (B)(6) 2015, 4568-53 LEAD IMPLANTED: (B)(6) 1999. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT "IT MOVED IN MY CHEST. WIRE IS COMING OUT OF MY CHEST. ". THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248713 SPRINT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC PUERTO RICO VILLALBA 6945-65

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization| R DTPA2D1 ICD.