Model Number 6345 |
Device Problems
High impedance (1291); Device Operates Differently Than Expected (2913)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 12/05/2014 |
Event Type
Injury
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Event Description
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Device 1 of 4.Reference mfr report: 1627487-2014-15899, reference mfr report: 1627487-2014-15900, reference mfr report: 1627487-2014-15901.It was reported the patient (b)(6) was involved in a motor vehicle accident approximately 2 months ago and afterwards diagnostics indicated high impedance readings.Reprogramming was unable to provide effective stimulation coverage.Surgical intervention was undertaken and intraoperative testing indicated high impedance readings.The patient's leads and extensions were explanted and replaced.
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Event Description
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Device 1 of 4 reference mfr report: 1627487-2014-15899 reference mfr report: 1627487-2014-15900 reference mfr report: 1627487-2014-15901.
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Event Description
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Device 1 of 4.Reference mfr report: 1627487-2014-15899 , reference mfr report: 1627487-2014-15900, reference mfr report: 1627487-2014-15901.Follow-up information indicated the patient's leads and extensions were not replaced as previously reported.
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Manufacturer Narrative
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This device is not approved for sale in the usa, but is similar to a usa marketed/approved device.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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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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