BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3073518 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06787
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    April 8, 2013
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3986ILC, LOT# N24016A, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: LEAD. PRODUCT ID 7495-25, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: EXTENSION. PRODUCT ID 7425, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3998 LOT# V003186, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT FOLLOWING THE FALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HAD "A BAD FALL" ON HER BACK AND COULDN'T USE THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT THE INS WOULDN'T HOLD CHARGE. IT WAS REPORTED THAT THE STIMULATION WENT IN HER STOMACH WHEN SHE TURNED IT ON HER BACK WHERE HER BATTERY WAS. IT WAS STATED THAT THE PAIN WAS "SO BAD." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR DOCTOR OR MEDTRONIC REPRESENTATIVE. IT WAS STATED THAT THE PATIENT HAD "NOT BEEN ABLE TO GET AN APPOINTMENT WITH THE DOCTOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175262 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1