BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4241132 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21245
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST 35 POUNDS, AND WHERE THE IMPLANT WAS LOCATED IT WAS IRRITATED AND SORE ALL THE TIME FOR THE LAST MONTH PRIOR TO THE REPORT. IT WAS NOTED SINCE LOSING THE WEIGHT THERE SEEMED TO BE NOTHING AROUND THE AREA OF THE IMPLANT, AND THE PATIENT¿S HUSBAND COULD FEEL THE IMPLANTABLE NEUROSTIMULATOR (INS). WHEN THE PATIENT WOULD LEAN AGAINST SOMETHING IT WOULD HURT. IT WAS CONFIRMED THE PATIENT WAS GETTING THERAPY RELIEF FROM THE IMPLANT. THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2014. A SUSPECTED POSSIBLE IMPEDANCE ISSUE WAS REPORTED. THE MANUFACTURER¿S REPRESENTATIVE (REP) WAS GOING TO MEET WITH THE PATIENT ON (B)(6) 2014. NO TROUBLESHOOTING HAD BEEN PERFORMED AT THE TIME OF THE REPORT. THE CAUSE OF THE ISSUE WAS NOT DETERMINED AND IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. THE PATIENT REPORTED SHE HAD FALLEN SEVERAL TIMES IN THE PAST SEVERAL MONTHS. IT WAS ALSO REPORTED THE BATTERY MOVED QUITE A BIT IN THE POCKET WHICH SHE ATTRIBUTED TO LOSING 30 POUNDS THE PAST SEVERAL MONTHS. AT THE TIME OF THE REPORT THE PATIENT WAS ALIVE WITH NO INJURY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE REP. FOLLOWED UP WITH THE PATIENT ON (B)(6). THE DEVICE WAS INTERROGATED AND AN IMPEDANCE CHECK WAS PERFORMED. THE IMPEDANCE CHECK WAS UNREMARKABLE. THE PATIENT WAS GETTING GOOD COVERAGE AND THE SYSTEM WAS OPERATING NORMALLY. IT WAS SUGGESTED TO THE PATIENT TO MAKE AN APPOINTMENT REGARDING THE IMPLANT SITE, BUT SHE INDICATED IF HER IMPLANT SITE CONTINUED TO IRRITATE HER, SHE WOULD CALL THE OFFICE AT A LATER DATE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723681 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97712

    Patients

    Seq Age Sex Outcome Treatment
    1