BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1192041 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06368
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HE WAS SITTING ON HIS PORCH DURING A STORM. WHEN LIGHTENING FLASHED ACROSS THE SKY, IT PICKED HIM UP FROM HIS LAWN CHAIR AND THREW HIM INTO HIS WIFE'S LAP. SINCE THAT TIME, THE PT HAD FELT A SURGING OR FADING SENSATION. THE PATIENT'S SYMPTOMS WERE LOCATED AT THE PARESTHESIA AREA. MOVEMENT DID NOT CAUSE THE STIMULATION TO CHANGE. THE PT INDICATED THAT THE SURGES WERE NOT PAINFUL, AND HE WAS HAPPY WITH THE DEVICE. THE PT WAS CONCERNED THAT HIS DEVICE HAD INTERACTED WITH THE LIGHTENING. THE PT WAS AT HOME AND HIS STATUS WAS REPORTED TO BE GOOD. THE PT WAS ENCOURAGED TO CONTACT HIS HEALTH CARE PROFESSIONAL (HCP) DUE TO THE TRAUMA OF BEING THROWN FROM THE LAWN CHAIR. ELEVEN DAYS LATER, THE PT CALLED AND STATED WIRES WERE COMING OUT OF THE INCISION SITE. THE PT SAW HIS HCP AND WAS TOLD THAT IT WAS UNDISSOLVABLE STITCHES THAT WERE COMING THROUGH AND NOT WIRES. THE HCP REMOVED THE STITCHES AND BANDAGED THE AREA. IN 2008, THE PT REPORTED CHARGING MORE THAN EXPECTED. INITIALLY, THE PT WAS ABLE TO CHARGE ONCE A MONTH, BUT NOW NEEDED TO KEEP THE RECHARGER ON THE STIMULATOR TO KEEP THE BATTERY CHARGED AND TURNED ON. HE ALSO STATED HE NEEDED TO RECHARGE AT LONGER AND LONGER INTERVALS (5-9 HRS). THE PT STATED HE WAS GOING TO HAVE A LEAD REPOSITIONED BECAUSE THE LEAD HAD FALLEN OUT OF PLACE. THE HCP REPORTED THAT THE PT EXPERIENCED WORSENING PAIN AND GREATER STIMULATION WITH THE USE OF THE STIMULATOR ON HIS LEFT THAN HIS RIGHT FOLLOWING A VIOLENT SNEEZE. SOME FEW DAYS LATER, THE LEAD WAS SURGICALLY REVISED; THE RIGHT LEAD WAS MOVED SUPERIORLY APPROX 3 MM. NO COMPLICATION OCCURRED DURING THE PROCEDURE. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| RECHARGER MODEL 33752| EXPLANTED| LEAD MODEL 3776| PROGRAMMER MODEL 37742| EXPLANTED| EXTENSION MODEL 37081| EXTENSION MODEL 37081| EXPLANTED| LEAD MODEL 3776