BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3998654 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-15067
    Event Type
    Injury
    Date Received
    August 11, 2014
    Report Date
    July 21, 2014
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION; PRODUCT ID 74002, LOT# N240242, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ADAPTER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3998, LOT# L95473, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS INTERROGATION AND REPROGRAMMING (B)(6) 2014 AND THE PATIENT WAS AWAITING A LE AD/EXTENSION EXPLORATION/REVISION. IT WAS NOTED THAT THERE WAS PROBABLY A LEAD/EXTENSION ¿MALFUNCTION.¿ HOWEVER, THE CAUSE WAS NOT DETERMINED AND IT WAS UNKNOWN IF IT WAS DEVICE RELATED. LASTLY, THE REPORTER ALSO NOTED ¿THIS FORM DID NOT REFLECT THE PATIENT¿S ISSUE.¿ NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THE SHOCKING WAS AT THE POCKET SITE. IT WAS REPORTED THE IMPEDANCES WERE WITHIN NORMAL LIMITS. IT WAS NOTED THERE MIGHT BE AN ISSUE WITH ELECTRODES ZERO THROUGH THREE. IT WAS REPORTED TURNING THOSE ELECTRODES OFF DID NOT RESOLVE THE ISSUE. IT WAS NOTED SHOCKING WAS NOT SPECIFIC TO POSITION AND DID NOT STOP UNTIL ALL STIMULATION WAS TURNED OFF. IT WAS REPORTED ONE OF THE CONNECTIONS WAS RESPONSIBLE. IT WAS NOTED THE SHOCKING WAS NOT ABLE TO BE REDUCED. IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR ADAPTOR REPLACEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HEALING AFTER AN EXPLORATION OF LEADS/CONNECTIONS/CONNECTOR WHICH TOOK PLACE ON (B)(6). THE PATIENT WAS AWAITING HEALING (B)(6) 2014. THERE WAS NO APPARENT RECURRENCE OF SYMPTOMS. IT WAS UNKNOWN IF THERE WAS 50% OR GREATER SYMPTOM REDUCTION. THE CAUSE OF EVENT WAS NOT DETERMINED. IT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE PATIENT OUTCOME WAS RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476454 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 00051 YR Required Intervention