Model Number 3788 |
Device Problems
No Device Output (1435); Use of Device Problem (1670); Communication or Transmission Problem (2896)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Event Description
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It was reported the patient's scs ipg is inoperable as the patient stopped using and charging his scs system approximately a year ago.An sjm representative met with the patient and confirmed the ipg would not communicate with external devices.Surgical intervention to explant and replace the ipg took place on (b)(6) 2014.
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Event Description
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Additional information received identified effective stimulation was reportedly restored postoperative.
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Manufacturer Narrative
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This ipg serial number was included in a field advisory.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Manufacturer Narrative
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Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Search Alerts/Recalls
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