Model Number 3788 |
Device Problems
Failure to Charge (1085); Nonstandard Device (1420); No Device Output (1435); Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 05/05/2015 |
Event Type
Injury
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Event Description
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Device 1 of 4.Reference mfr.Report#: 1627487-2015-23303, reference mfr.Report#: 1627487-2015-23304, reference mfr.Report#: 1627487-2015-23305.The patient has 2 scs systems: thoracic and cervical.It was reported the patient was unable to establish communication between her ipg (cervical system) and external devices.It was also reported the patient's ipg was inoperable.Follow-up information revealed the patient also stated she was not receiving adequate pain relief from the cervical system.Subsequently, the patient underwent surgical intervention on (b)(6) 2015, where the system was removed.Please note: it was undetermined which of the patient's ipgs was inoperable; therefore, both are being reported.
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Manufacturer Narrative
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Correction number: 1627487-12192011-003-r.This ipg serial number was included in field advisories.Udi (di): (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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Device 1 of 4.Reference mfr.Report#: 1627487-2015-23303, reference mfr.Report#: 1627487-2015-23304, reference mfr.Report#: 1627487-2015-23305.Follow-up information revealed the patient's cervical system (model 3788) was inoperable.
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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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