BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2924526 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00801
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 2, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V044336, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-39, LOT# N233478, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS NOT HAPPY WITH THEIR LOSS OF THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE. IT WAS ALSO REPORTED THE PATIENT'S DEVICE HAD NOT BEEN "WORKING RIGHT" FOR MONTHS AND THEY DID NOT RECEIVE ANY "GOOD RELIEF."

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTENSIONS AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE REPLACED. IT WAS NOTED THERE WERE 'ISSUES' WITH THE SYSTEM, EXACT ISSUES WERE UNKNOWN. IT WAS ALSO NOTED THE REPRESENTATIVE WAS AT THE HOSPITAL WHEN THE PATIENT 'WAS GOING IN' HOWEVER THE REPRESENTATIVE WAS NOT AWARE THERE WAS ANYTHING WRONG. IT WAS NOTED THE REPRESENTATIVE INTERROGATED THE INS AND STATED THERE WAS 'SOMETHING WRONG.' IT WAS NOTED AFTER SURGERY THE HEALTH CARE PROVIDER INFORMED THE PATIENT THERE WAS FLUID IN THE INS POCKET AND THE WIRES WERE TWISTED AROUND WITH ADHESIONS. THEY MOVED THE LOCATION OF THE INS TO THE OTHER SIDE AND REPLACED THE 'WIRES.' IT WAS NOTED THE PATIENT WAS UNDER FULL ANESTHESIA BECAUSE OF 'THE NEED FOR MORE SURGERY GIVEN WHAT THEY SAW IN THE POCKET AREA.' IT WAS NOTED THE PATIENT HAD NOT HAD STIMULATION SINCE THEIR REPLACEMENT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30490 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention