BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1072071 · Received July 10, 2008

    Report

    Report Number
    2182208-2008-00232
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 31, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTD
    PMA / PMN Number
    ASKU
    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. CORRECTED EXPLANT DATE FOR 2872 ADAPTOR. EVALUATION SUMMARY: (B) (4) NO ANOMALIES FOUND; FULL LEAD ANALYZED. NUMEROUS SETSCREW MARKS WERE ON THE IS-1 PIN AND MORE THAN ONE ARE TOO PROXIMAL, INDICATING THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE. (B) (4): NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: NO ANOMALIES FOUND; FULL LEAD ANALYZED. NUMEROUS SETSCREW MARKS WERE ON THE IS-1 PIN AND MORE THAN ONE ARE TOO PROXIMAL, INDICATING THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE.

    Description of Event or Problem · 1

    LOSS OF CAPTURE WAS REPORTED. THE ADAPTOR WAS EXPLANTED AND REPLACED. TWO NEW DEVICES WERE ATTEMPTED, BUT BOTH RESULTED IN NO CAPTURE. THE DEVICES WERE NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    LOSS OF CAPTURE WAS REPORTED. THE ADAPTOR WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * IMPLANTABLE LEAD ADAPTOR DTD MEDTRONIC, INC. 2872 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5071 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6945 IMPLANTABLE TACHY LEAD