Model Number 3716 |
Device Problems
Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/15/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported the patient experienced difficulty locating his ipg with external devices and an increased recharge burden.Surgical intervention took place on (b)(6) 2015 at which time the ipg was explanted and replaced.Effective therapy was reportedly restored postoperative.
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Manufacturer Narrative
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Device evaluation codes updated based upon further device analysis performed.
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Search Alerts/Recalls
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