BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1718625 · Received June 11, 2010

    Report

    Report Number
    2649622-2010-06405
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    April 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 YEARS POST IMPLANT THE IMPEDANCE IS IN THE 200-300 OHM RANGE WITH LESS THAN 200 OHMS OCCATIONALLY. RECENT INTERROGATION REVEALED DETECTION DUE TO NOISE. DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 YEARS POST IMPLANT THE IMPEDANCE IS IN THE 200-300 OHM RANGE WITH LESS THAN 200 OHMS OCCASIONALLY. RECENT INTERROGATION REVEALED DETECTION DUE TO NOISE. IT WAS ALSO REPORTED THAT THERE WAS AN ALERT FOR THE SUPERIOR VENA COIL OF THE RIGHT VENTRICULAR LEAD FOR HIGH IMPEDANCE. THE COIL WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 YEARS POST IMPLANT, THE IMPEDANCE IS IN THE 200-300 OHM RANGE WITH LESS THAN 200 OHMS OCCASIONALLY. RECENT INTERROGATION REVEALED DETECTION DUE TO NOISE. DEVICE REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THE LEAD IS BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6942 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O| R 5524M IMPLANTABLE PACING LEAD| 5524M IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5524M IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB