BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 1992301 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02751
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS LEAD AND DEVICE MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - VARYING RESISTANCE/IMPEDANCE; WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS MAX VENTRICULAR PACE BI IMPEDANCE VARYING, FROM RV PACE EQUALS 475 TO 1026 OHMS PEAK BETWEEN (B)(6) 2010 TO (B)(6) 2010, THEN RETURNING TO 532 OHMS ON (B)(6) 2010. (B)(4): THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. HOWEVER, BLOOD/BODY FLUID WAS NOTED ON THE OUTER TUBING OVERLAY, THE INNER TUBING WAS KINKED/BUCKLED, BLOOD WAS NOTED IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD) AND ON THE HELIX/LOBE MECHANISM, THE LEAD WAS STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. HOWEVER, BLOOD/BODY FLUID WAS NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED) AND THERE WAS AN OUTER INSULATION COSMETIC DEPRESSION. THE RIGHT VENTRICULAR LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS LEAD NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLD, AND THE LEFT VENTRICULAR LEAD EXHIBITED A LOSS OF CAPTURE. THE DEVICE HAD APPARENTLY MIGRATED WITHIN THE POCKET, WHICH CAUSED THE LEADS TO DISLODGE. BOTH OF THE VENTRICULAR LEADS WERE EXPLANTED AND REPLACED, AND THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY PLUS IMPLANTABLE PACING LEAD LWS MEDTRONIC PUERTO RICO, INC. 4296 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD