BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II VR

    MDR report key: 2955243 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-01857
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    June 7, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE HAD FOREIGN MATERIAL IN THE CONNECTOR. THE RETURNED DEVICE HAD A DAMAGED CONNECTOR. THE RETURNED DEVICE INDICATED A MISSING GROMMET. THE RETURNED DEVICE INDICATED A GROMMET ISSUE. THE RETURNED DEVICE INDICATED A DAMAGED GROMMET. THE RETURNED DEVICE INDICATED FOREIGN MATERIAL ON SET SCREW. THE RETURNED DEVICE INDICATED A SET SCREW WITH A ROUNDED SOCKET. THE RETURNED DEVICE INDICATED A DAMAGED SET SCREW. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DEVICE SETSCREW WAS UNABLE TO BE ENGAGED TO TIGHTEN OR TO RETRACT. THE PHYSICIAN DECIDED TO REMOVE THE GROMMET SEAL AND USE SILICONE ADHESIVE TO REPLACE IT AFTER LOCATING THE SETSCREW AND PULLING IT BACK INTO THE DEVICE. THE DEVICE WAS IMPLANTED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AT EXPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE HEADER/GROMMET APPEARED "MELTED" AND THE CAN APPEARED TO BE BURNT AND BROWN. THE PATIENT HAD REPORTED REDNESS/SORENESS IN THE ICD POCKET. ADDITIONALLY, THE PHYSICIAN REPORTED THAT THE PATIENT HAD EXPERIENCED MULTIPLE INAPPROPRIATE THERAPIES WHEN THE ICD DETECTED ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EVENTS AS VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) EVENTS. THE DEVICE WAS EXTRACTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58390 MAXIMO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization| L| R