Model Number 3660 |
Device Problems
Device Inoperable (1663); Communication or Transmission Problem (2896)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 12/07/2016 |
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.(b)(4).
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Event Description
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It was reported the patient ((b)(6)) lost stimulation.Troubleshooting by an sjm representative identified the patient's ipg was unable to communicate with external devices.In turn, surgical intervention was undertaken to explant and replace the ipg which resolved the issue.
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Manufacturer Narrative
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The capa was initiated on (b)(6) 2016 to address the issue in which the ipg experienced loss of power, causing the patient to lose pain relief requiring replacement of the device.Investigation is currently in progress.
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Manufacturer Narrative
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The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.
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Search Alerts/Recalls
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