BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4111153 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17560
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, LOT NUMBER V079881, FOUND NO SIGNIFICANT ANOMALY. ANALYSIS OF THE LEAD, LOT NUMBER V155384, FOUND NO SIGNIFICANT ANOMALY. ANALYSIS OF THE LEAD, LOT NUMBER V105542, FOUND NO SIGNIFICANT ANOMALY. ANALYSIS OF THE LEAD, LOT NUMBER V155384, FOUND NO SIGNIFICANT ANOMALY. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-45, LOT# V155384, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V079881, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V079881, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V155384, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3888-45, LOT# V105542, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V155384, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER; PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 3888-45, LOT# V105542, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V155384, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-45, LOT# V155384, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V079881, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V079881, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V155384, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3888-45, LOT# V105542, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V155384, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 3888-45, LOT# V105542, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V155384, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A FEW WEEKS LATER IT WAS CONFIRMED THAT THE PATIENT HAD AN INFECTION AT THE LEAD LOCATION. THE TYPE OF INFECTION WAS UNKNOWN. IT WAS UNKNOWN IF A CULTURE WAS TAKEN OR IF ANTIBIOTIC TREATMENT WAS NECESSARY. THE DATE OF ONSET WAS UNKNOWN. DIAGNOSTIC TESTING AND TROUBLESHOOTING WAS NOT REQUIRED. THE PATIENT REQUESTED EXPLANT SO THE DEVICE SYSTEM WAS EXPLANTED. THE PATIENT CURRENTLY DID NOT HAVE AN INFECTION AND WAS ALIVE WITHOUT INJURY. RECOVERED WITHOUT SEQUELA WAS CONFIRMED. IT WAS NOTED THE DEVICE WAS USED IN AN OFF LABEL MANNER. THE LEADS WERE PLACED UNDER THE SKIN, IN THE PATIENT'S HEAD. INS WAS PLACED IN THE UPPER RIGHT CHEST AREA.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT A WIRE STICKING OUT. THE PATIENT COULD NOT SEE IT, BUT COULD FEEL IT STICKING OUTSIDE OF THEIR SKIN. THE PATIENT HAD CLARIFIED THE WIRE HAD COME THROUGH THE SKIN. THE PATIENT MENTIONED THEY COULD FEEL IT GETTING INFECTED AND THEY WANTED AN EXPLANT. 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
    592156 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention