BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3833406 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09635
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE INFECTION. SPECIFICALLY, THE NURSE PRACTIONER (NP) FELT AS THOUGH THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY (POCKET) SITE WAS INFECTED AT A FOLLOW UP VISIT ON (B)(6) 2014. THE PATIENT SYMPTOM OF REDNESS AT THE DEVICE POCKET WAS REPORTED. SURGICAL EXPLORATION WAS PERFORMED ON (B)(6) 2014 WHERE IT WAS DETERMINED THAT THE INS AS NOT INFECTED. A CULTURE OF THE DEVICE POCKET (RESULTS NOT PROVIDED). IT WAS UNKNOWN IF ANTIBIOTIC TREATMENT WAS NECESSARY FOR THE ISSUE. TROUBLESHOOTING OF REPROGRAMMING WAS PERFORMED. THE INS WAS LEFT IMPLANTED AND WAS NOT REMOVED. IT WAS NOTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE ASSOCIATED WITH THE EVENT. THE PATIENT STATUS AT THE TIME OF REPORT WAS REPORTED AS ¿ALIVE ¿ NO INJURY¿. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S SYMPTOMS RESOLVED AND THE POCKET WAS SURGICALLY CHECKED AND IT WAS DETERMINED THERE WAS NO INFECTION. IT WAS NOTED THE PATIENT'S HEALTH CARE PROVIDER (HCP) BELIEVES IT WAS SIMPLY BRUISING. IT WAS FURTHER REPORTED THE PATIENT IS NOW RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310571 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention