BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA

    MDR report key: 1791966 · Received August 10, 2010

    Report

    Report Number
    2647346-2010-00354
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    January 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 THE RV THRESHOLD HAS BEEN HIGH SINCE IMPLANT. IT WAS ALSO REPORTED THE IMPEDANCE FLUCTUATED FROM 500 TO GREATER THAN 3000 OHMS. IT WAS NOTED THAT THE SVC SET SCREW WAS LOOSE BENEATH THE GROMMET. THE LEAD WAS REPOSITIONED AND IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING THE SETSCREW REVISION, THERE WAS A BREACH NOTED IN THE PLASTIC COVERING OF THE SVC COIL PORT "GENERATOR HEAD". THE BREACH WAS REPAIRED WITH SILICONE AND THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE DAY AFTER IMPLANT THE ATRIAL LEAD HAD POOR SENSING DUE TO PATIENT PHYSIOLOGY. THE LEAD WAS REPOSITIONED AND REMAINS ACTIVE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT WITHIN A YEAR OF IMPLANT, THE PATIENT EXPERIENCED A LOSS OF ATRIAL CAPTURE. THE LEAD DISLODGED CAUSING A PROLONGED HOSPITAL STAY FOR THE PATIENT. THE LEAD WAS REPOSITIONED AND REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RV THRESHOLD HAS BEEN HIGH SINCE IMPLANT. IT WAS ALSO REPORTED THE IMPEDANCE FLUCTUATED FROM 500 TO GREATER THAN 3000OHMS. IT WAS NOTED THAT THE SVC SET SCREW WAS LOOSE BENEATH THE GROMMET. THE LEAD WAS REPOSITIONED AND IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING THE SETSCREW REVISION, THERE WAS A BREACH NOTED IN THE PLASTIC COVERING OF THE SVC COIL PORT "GENERATOR HEAD". THE BREACH WAS REPAIRED WITH SILICONE AND THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE DAY AFTER IMPLANT THE ATRIAL LEAD HAD POOR SENSING DUE TO PATIENT PHYSIOLOGY. THE LEAD WAS REPOSITIONED AND REMAINS ACTIVE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RV THRESHOLD HAS BEEN HIGH SINCE IMPLANT. IT WAS ALSO REPORTED THE IMPEDANCE FLUCTUATED FROM 500 TO >3000OHMS. IT WAS NOTED THAT THE SVC SET SCREW WAS LOOSE BENEATH THE GROMMET. THE LEAD WAS REPOSITIONED AND IS STILL IN USE. IT WAS FURTHER REPORTED THAT DURING THE SETSCREW REVISION, THERE WAS A BREACH NOTED IN THE PLASTIC COVERING OF THE SVC COIL PORT "GENERATOR HEAD". THE BREACH WAS REPAIRED WITH SILICONE AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 4195 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD