BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3790627 · Received May 5, 2014

    Report

    Report Number
    6000032-2014-00088
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7436, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT # J0340564V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT # J0340523V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748266, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7426, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2006, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7438, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ORIGINALLY HAD ONE IMPLANTABLE NEUROSTIMULATOR (INS) IN HER CHEST AND ANOTHER ON THE LOWER LEFT SIDE BELOW HER RIBS. THE REPORTER STATED THAT A FEW YEARS LATER BOTH INS¿S WERE REPLACED WITH ONLY ONE IN THE PATIENT¿S UPPER LEFT SIDE CHEST. THE REPORTER DID NOT KNOW THE REASON FOR REPLACEMENT, BUT IT MAY HAVE BEEN BECAUSE THE ONE INS BELOW HER RIBS CAUSED HER DISCOMFORT. THE REPORTER STATED THAT HE REALLY DID NOT KNOW IF THAT WAS THE REASON FOR REPLACEMENT AT THE TIME, BUT IT COULD BE A FACTOR. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268494 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT SOFAMOR DANEK PUERTO RICO MFG 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention