BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2250648 · Received September 9, 2011

    Report

    Report Number
    3004209178-2011-07621
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 18, 2011
    Report Date
    November 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED NO ANOMALY FOUND - INS HAS REDUCED BATTERY CAPACITY DUE TO OVERDISCHARGE. TELEMETRY WAS RESTORED WITH THE DEVICE AFTER ONE PHYSICIAN MODE RECHARGE. FINAL ANALYSIS OF THE EXTENSIONS REVEALED NO SIGNIFICANT ANOMALIES, EXTENSIONS WERE CUT THROUGH, SUSPECTED EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THE DEVICE HAD BEEN OVERDISCHARGED, AND REPORTED THIS WAS THE SECOND TIME THE DEVICE HAD B EEN IN AN OVERDISCHARGED STATE. A PHYSICIAN MODE RECHARGE WAS ATTEMPTED BUT WAS UNSUCCESSFUL IN RESETTING THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD PROGRESSIVE DIFFICULTY WITH RECHARGING THE DEVICE. THE DEVICE WAS IN AN OVER-DISCHARGED STATE AND A TRICKLE CHARGE COULD NOT BE OBTAINED. THE DEVICE WAS EXPLANTED AND THE PT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD MODEL 3998 LOT# V131835 IMPLANTED: (B)(4)| EXTENSION: MODEL 37083, LOT# NKC017636N| LEAD: MODEL 3998, LOT# V131835| ACCESSORY: MODEL 37752, LOT# NKA129027N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE100343N| EXTENSION: MODEL 37083, LOT# NKC017634N