Model Number 3186 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Vomiting (2144)
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Event Type
Injury
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Manufacturer Narrative
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Results; lead migration could not be confirmed via product testing.However, the returned lead was inspected and continuity testing revealed one "open" channel.Since only one broken wire was observed it was concluded that the opens found are consistent with electrical opens at the channel weld sites.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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Event Description
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The patient had two leads from the same lot.It was reported the patient had been experiencing extreme vomiting (event date is unknown).In turn, the doctor believed the vomiting was related to lead migration.X-rays were taken and revealed one of the patient's leads had migrated.As a result, the doctor decided to explant and replace the lead that had migrated.The doctor also electively explanted and replaced the patient's anchors.Surgical intervention resolved the patient's issue.
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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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Search Alerts/Recalls
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