BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 2042261 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01372
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    August 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PHYSICIAN THAT "LIGHT TRACTION WAS USED DURING THE EXPLANT PROCEDURE". THE EXTENT OF LEAD DAMAGE IS LIKELY DUE TO EXPLANT HANDLING, HOWEVER, GIVEN THE CLINICAL OBSERVATIONS AND THE FACT THAT LIGHT TRACTION WAS USED DURING EXPLANT IT IS UNKNOWN WHETHER THE ORIGINAL BOND SEPARATION WAS INITIATED WHILE IMPLANTED OR DURING THE EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. DIRECT CURRENT RESISTANCE TESTING CONFIRMED THE CONDUCTIVE PATHS OF THE LEAD TO BE WITHIN SPECIFICATION. FURTHER ANALYSIS REVEALED TIP/MOLDED NECK SEPARATION, LIKELY OCCURRING AT THE EXPLANT PROCEDURE. NO FURTHER TESTING WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION IN (B)(6) 2011 THAT THE PATIENT HAS RETAINED AN ATTORNEY AND RECENTLY SUBMITTED PAPERWORK AS PART OF THE LITIGATION PROCESS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC), WITH INCREASED THRESHOLD MEASUREMENTS. DECREASED IMPEDANCE MEASUREMENTS WERE OBSERVED, ALTHOUGH REMAINING WITHIN ACCEPTABLE LIMITS. AN INSULATION BREAK WAS SUSPECTED. ADDITIONALLY, LOC WAS OBSERVED ON THE LV LEAD. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND BOTH LEADS WERE EXPLANTED AND REPLACED. NO FURTHER COMPLICATIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4055

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R 4054| H120| 4055| 4591| 4473