Model Number 3660 |
Device Problem
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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Manufacturer Narrative
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Concomitant product(s): the therapy date for the following device is unknown: model: 3228; scs lead.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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It was reported (b)(6) the patient's ipg would no longer connect with the patient or clinician programmer.The patient reportedly underwent a few surgeries since the implantation of the ipg.The patient does not have stimulation currently.Surgical intervention is planned to address the issue.The manufacturer has requested additional details on the device.
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Event Description
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Additional information received identified the ipg was explanted and replaced with another model which resolved the issue.
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Search Alerts/Recalls
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