BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1686994 · Received May 13, 2010

    Report

    Report Number
    2649622-2010-02157
    Event Type
    Death
    Date Received
    May 13, 2010
    Date of Event
    June 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    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 LEAD IS PART OF THE ADVISORY FOR THIS MODEL. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE PATIENT IS INVOLVED IN A SETTLEMENT INVOLVING THE SPRINT FIDELIS LEADS. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. UPON INSPECTION, IT WAS NOTED THAT THE PROXIMAL CONDUCTOR OF THE LEAD WAS DISTORTED AND STRETCHED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE INNER AND OUTER INSULATION OF THE LEAD WAS BREACHED. UPON INSPECTION, IT WAS NOTED THAT THE HELIX/LOBE OF THE LEAD WAS DISTORTED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE LEAD WAS DAMAGED DURING THE IMPLANT PROCESS.

    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: (B) (4) NO ANOMALIES FOUND. UPON INSPECTION IT WAS NOTED THAT THE PROXIMAL CONDUCTOR OF THE LEAD WAS DISTORTED AND STRETCHED. UPON VISUAL INSPECTION IT WAS NOTED THAT THE INNER AND OUTER INSULATION OF THE LEAD WAS BREACHED. UPON INSPECTION IT WAS NOTED THAT THE HELIX/LOBE OF THE LEAD WAS DISTORTED. UPON VISUAL INSPECTION IT WAS NOTED THAT THE LEAD WAS DAMAGED DURING THE IMPLANT PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV (6949) LEAD WAS OVERSENSING, AND CLINIC NOTES SHOW THIS WAS OCCURRING FROM ONE MONTH POST IMPLANT, MORE THAN 2 YRS PREVIOUSLY. A CHEST X-RAY SHOWED THAT A PREVIOUSLY ABANDONED LEAD WAS POSITIONED IN PROXIMITY TO THE RV LEAD AND THE COILS WERE TOUCHING. IT WAS BELIEVED THE NOISE WAS DUE TO THIS CLOSE PROXIMITY. THE DR FELT THE PT WAS NOT A GOOD CANDIDATE FOR LEAD EXTRACTION AND CHOSE TO IMPLANT A NEW LEAD, TO REPLACE THE P/S PORTION OF THE LEAD. WITH THE FIRST REPLACEMENT LEAD THAT WAS ATTEMPTED (5076), THE DR NOTICED THE PIN FELT 'VERY LOOSE AND BECAME SEPARATED FROM THE INSULATION'. THE HELIX DID NOT SEEM TO DEPLOY AFTER 12 TURNS, AND IT WAS REPLACED WITH A NEW LEAD. (B) (6) A LAWSUIT ALLEGES THE PT EXPERIENCED INAPPROPRIATE SHOCKS, FRACTURE "OR OTHER INJURY REQUIRING MEDICAL INTERVENTION" DUE TO THE LEAD. THE 5076 LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV (6949) LEAD WAS OVERSENSING, AND CLINIC NOTES SHOW THIS WAS OCCURRING FROM ONE MONTH POST IMPLANT, MORE THAN 2 YRS PREVIOUSLY. A CHEST X-RAY SHOWED THAT A PREVIOUSLY ABANDONED LEAD WAS POSITIONED IN PROXIMITY TO THE RV LEAD AND THE COILS WERE TOUCHING. IT WAS BELIEVED THE NOISE WAS DUE TO THIS CLOSE PROXIMITY. THE DR FELT THE PT WAS NOT A GOOD CANDIDATE FOR LEAD EXTRACTION AND CHOSE TO IMPLANT A NEW LEAD, TO REPLACE THE P/S PORTION OF THE LEAD. WITH THE FIRST REPLACEMENT LEAD THAT WAS ATTEMPTED (5076), THE DR NOTICED THE PIN FELT 'VERY LOOSE AND BECAME SEPARATED FROM THE INSULATION'. THE HELIX DID NOT SEEM TO DEPLOY AFTER 12 TURNS, AND IT WAS REPLACED WITH A NEW LEAD. (B)(6) 2009: A LAWSUIT ALLEGES THE PT EXPERIENCED INAPPROPRIATE SHOCKS, FRACTURE "OR OTHER INJURY REQUIRING MEDICAL INTERVENTION" DUE TO THE LEAD. THE 5076 LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE RV (6949) LEAD WAS OVERSENSING, AND CLINIC NOTES SHOW THIS WAS OCCURRING FROM ONE MONTH POST IMPLANT, MORE THAN 2 YRS PREVIOUSLY. A CHEST X-RAY SHOWED THAT A PREVIOUSLY ABANDONED LEAD WAS POSITIONED IN PROXIMITY TO THE RV LEAD AND THE COILS WERE TOUCHING. IT WAS BELIEVED THE NOISE WAS DUE TO THIS CLOSE PROXIMITY. THE DR FELT THE PT WAS NOT A GOOD CANDIDATE FOR LEAD EXTRACTION AND CHOSE TO IMPLANT A NEW LEAD, TO REPLACE THE P/S PORTION OF THE LEAD. WITH THE FIRST REPLACEMENT LEAD THAT WAS ATTEMPTED (5076), THE DR NOTICED THE PIN FELT 'VERY LOOSE AND BECAME SEPARATED FROM THE INSULATION'. THE HELIX DID NOT SEEM TO DEPLOY AFTER 12 TURNS, AND IT WAS REPLACED WITH A NEW LEAD. (B)(6) 2009: A LAWSUIT ALLEGES THE PT EXPERIENCED INAPPROPRIATE SHOCKS, FRACTURE "OR OTHER INJURY REQUIRING MEDICAL INTERVENTION" DUE TO THE LEAD. THE 5076 LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2011: AN ALLEGATION FROM AN......

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| R