BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1802774 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08688
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    March 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K896313
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. EVALUATION SUMMARY: (B)(4) INNER INSULATION BREACHED. VISUAL ANALYSIS REVEALED THE OUTER INSULATION WAS MELTED AND BREACHED CUT. THE FULL LEAD WAS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND; IT WAS OBSERVED THAT THE HELIX AND GUIDE TOOTH WERE BENT, DAMAGED AT IMPLANT; BLOOD ON HELIX. THE FULL LEAD RETURNED AND ANALZYED.

    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): INNER INSULATION BREACHED. VISUAL ANALYSIS REVEALED THE OUTER INSULATION WAS MELTED AND BREACHED CUT. THE FULL LEAD WAS RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND; IT WAS OBSERVED THAT THE HELIX AND GUIDE TOOTH WERE BENT, DAMAGED AT IMPLANT; BLOOD ON HELIX. THE FULL LEAD RETURNED AND ANALZYED. STYLET: NO ANOMALIES FOUND, HOWEVER STYLET WAS BENT AND DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD APPARENT CONDUCTOR FRACTURE. THE LEAD WAS NOTED TO HAVE BEEN UNIPOLARIZED. THE LEAD WAS REMOVED AND REPLACED. A LEAD WAS RECEIVED WITH NO INFORMATION WHICH APPEARED TO BE AN ATTEMPTED BUT NOT IMPLANTED LEAD. FOLLOW-UP WILL BE CONDUCTED TO DETERMINE WHY THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD APPARENT CONDUCTOR FRACTURE. THE LEAD WAS NOTED TO HAVE BEEN UNIPOLARIZED. THE LEAD WAS REMOVED AND REPLACED. DURING THE IMPLANT ATTEMPT OF THE NEW LEAD, IT WAS REPORTED THAT THE STYLET BECAME KINKED IN THE LEAD AND THERE WAS DIFFICULTY REMOVING THE STYLET FROM THE LEAD. THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN ASKU DTB MEDTRONIC PUERTO RICO, INC. 4058M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention 5024M IMPLANTABLE PACING LEAD| VEDR01 IMPLANTABLE PULSE GENERATOR| VEDR01 IMPLANTABLE PULSE GENERATOR| 5024M IMPLANTABLE PACING LEAD