BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2853383 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-11013
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 5, 2012
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V004644, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS SHOCKING AND JOLTING SENSATION. IT WAS NOTED THE PATIENT WAS REPORTING SHOCKING AND THE NURSE AT THE NURSING REHAB FACILITY TOOK THE PATIENT'S PROGRAMMER AWAY AND WOULD FOR THE PATIENT TO BE SEEN. FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE PATIENT HAD NOT BEEN SEEN SINCE 2006. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT MARKED THAT HE DID NOT HAVE CONCERNS WITH HIS DEVICE OR THERAPY AND WROTE 'NO' NEXT TO THAT. ADDITIONALLY IT WAS STATED THAT THE PATIENT RECEIVED ASSISTANCE FROM A MEDTRONIC REPRESENTATIVE AND HIS CONCERNS WERE RESOLVED. THE APPOINTMENT DATE WAS (B)(6) 2012. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1