BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1021618 · Received March 26, 2008

    Report

    Report Number
    6000032-2008-01580
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    October 31, 2007
    Report Date
    February 28, 2008
    Manufacturer
    MEDTRONIC MEL REL, INC.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-0694-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF FINAL DEVICE ANALYSIS REVEALED THE EPOXY BOND WAS BROKEN BETWEEN THE HYBRID CIRCUIT AND BOTH BATTERY TERMINALS, INTERNAL TO THE DEVICE. FINDINGS FROM DESTRUCTIVE ANALYSIS DETERMINED THAT BOTH OF B-BOND WIRES AND ONE OF THE B+ BATTERY BOND WIRES WERE LIFTED FROM THEIR RESPECTIVE HYBRID BOND PADS, AS RECEIVED. RETURNED PRODUCT INSPECTION SHOWED THAT PRIOR TO THE DECONTAMINATION PROCESS, TELEMETRY HAD BEEN ESTABLISHED. SUBSEQUENT TO DECONTAMINATION AND DURING FUNCTION TESTING, NO OUTPUT OR TELEMETRY HAD BEEN DETECTED. ANALYSIS RESULTS CONFIRM THE REASON FOR DEVICE RETURN.

    Description of Event or Problem · 1

    THE PT WAS SEEN FOR INSPECTION OF THE INS; THE DEVICE SERIAL NUMBER HAD BEEN WITHIN THE AFFECTED RANGE FOR THE MFS LIFTED WIRE BOND FIELD ACTION. AT FOLLOW-UP, THE BATTERY COULD BE INTERROGATED WITH THE PROGRAMMER (TELEMETRY READING WERE NOT PROVIDED); NO SYMPTOMS WERE REPORTED. THE BILATERAL PULSE GENERATORS WERE REPLACED FOR POSSIBLE BATTERY DEPLETION. NO PT INJURY WAS ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC MEL REL, INC. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR IMPLANTED| EXPLANTED| MODEL 7426 LOT#NFW111118H| EXPLANTED| IMPLANTED| EXPLANTED| EXTENSION MODEL 7482 LOT # NGK016697N| EXPLANTED| IMPLANTED| LEAD MODEL 3389 LOT# J0211884V| IMPLANTED| LEAD MODEL 3389 LOT # J0211884V| IMPLANTED| EXTENSION MODEL 7482 LOT#NGK017681N| EXPLANTED| IMPLANTED| PROGRAMMER MODEL UNK LOT#UNK| RIGHT-SIDED IMPLANTABLE NEURO STIMULATOR