BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4366273 · Received December 29, 2014

    Report

    Report Number
    3004209178-2014-24597
    Event Type
    Injury
    Date Received
    December 29, 2014
    Report Date
    December 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-45, LOT # V057996, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V062150, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 37713, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3888-56, LOT # V061227, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888-56, LOT # V061227, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V059034, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V059034, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR FIRST IMPLANTABLE NEUROSTIMULATOR (INS) TAKEN OUT ON (B)(6). AFTER THE SURGERY THEY DID NOT RECOVER VERY WELL SO THEY HAD TO TAKE THE PATIENT BACK TO TAKE OUT THEIR SECOND INS. AFTER THE PATIENT HAD THEIR SECOND IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED ON (B)(6) THEY HAD A HARD TIME GETTING STABILIZED AND THEY HAD TO STAY OVERNIGHT IN THE HOSPITAL. THE NURSE CALLED THE EVENT A ¿SENTINEL EVENT.¿ THE PATIENT¿S BLOOD PRESSURE DROPPED TO 80/49. NO OUTCOME WAS 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. FOR INFORMATION REGARDING THE PATIENT'S OTHER EXPLANTED DEVICE PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2014-24591.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853900 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 00040 YR Hospitalization| R