BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4012407 · Received August 15, 2014

    Report

    Report Number
    3004209178-2014-15375
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    January 9, 2014
    Report Date
    March 13, 2020
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3487A-45, LOT# V183264, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-45, LOT# V101634, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3487A-45, LOT# V183264, IMPLANTED: (B)(6) 2009-06-05, PRODUCT TYPE: LEAD; PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3487A-45, LOT# V101634, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3487A-45, LOT# V183264, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3487A-45, LOT# V101634, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3 487A-45, LOT# V183264, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3487A-45, LOT# V101634, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3487A-45, LOT# V183264, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3487A-45, LOT# V101634, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD IMPEDANCE WAS OUT OF RANGE GREATER THAN 10,000 OHMS. THE DEVICE INTERROGATION WAS PERFORMED ON (B)(6) 2014 AND NO INTERVENTIONS WERE TAKEN. IT WAS RELATED TO THE DEVICE OR THERAPY AND POSSIBLE RELATED TO THE IMPLANT PROCEDURE. THERE WERE NO SIGNS OR SYMPTOMS AND THE OUTCOME OF THE EVENT WAS ONGOING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) IN A CLINICAL STUDY. IT WAS REPORTED THAT THE DEVICE WAS REPROGRAMMED ON (B)(6) 2014 AND THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP). IT WAS REPORTED THAT X-RAYS WERE PERFORMED ON (B)(6) 2015 AND SHOWED DISTINCT MIGRATION OF THE RIGHT OCTAD LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489709 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR