BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4118185 · Received September 25, 2014

    Report

    Report Number
    3004209178-2014-17708
    Event Type
    Injury
    Date Received
    September 25, 2014
    Report Date
    September 22, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3550-29, LOT# N152709, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS (B)(4), FOUND NO ANOMALY. (B)(4)

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER DEVICE REPLACED WITH A NON-RECHARGEABLE DEVICE AS THE PATIENT HAD DIFFICULTY CHARGING/GETTING A GOOD CONNECTION. THE DEVICE WAS IN THE SKIN FOLD OF HER ABDOMEN, AND DUE TO WEIGHT GAIN, IT MADE IT DIFFICULT FOR THE PATIENT TO CHARGE. PRIOR TO THE WEIGHT GAIN, THE PATIENT HAD BEEN ABLE TO RECHARGE. THE RECHARGING ISSUES HAD STARTED APPROXIMATELY 2 MONTHS PRIOR TO THE REPORT. A COMPANY REPRESENTATIVE HAD WORKED WITH THE PATIENT TO TRY TO ENABLE HER TO RECHARGE BUT SHE STILL HAD PROBLEMS CHARGING. THE STIMULATOR WAS TAKING A CHARGE; IT WAS JUST DIFFICULT TO CHARGE DUE TO THE WEIGHT GAIN. THE COMPANY REPRESENTATIVE HAD TO PUT A LOT OF PRESSURE TO GET 6 COUPLING BARS. THE PRIOR DEVICE COULD NOT BE INTERROGATED AS IT WAS DEAD. THE COMPANY REPRESENTATIVE HAD NOT SPOKEN TO THE PATIENT SINCE THE REPLACEMENT BUT PLANNED TO CONTACT HER FOR A FOLLOW UP APPOINTMENT. ADDITIONAL INFORMATION ABOUT THE OUTCOME/PATIENT RECOVERY WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT THE HEALTHCARE PROFESSIONAL USED THE INS PLUG OUT OF THE PREVIOUS INS. THE PATIENT WOULD BE TURNING THEIR STIMULATION ON IN A COUPLE WEEKS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE EXPLANT WAS DUE TO WEIGHT GAIN AND CHARGING PROBLEMS. THE INS WAS REPLACED WITH A NON-RECHARGEABLE INS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597197 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 00049 YR Required Intervention