Model Number 3186 |
Device Problems
Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508)
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Patient Problems
Myocardial Infarction (1969); Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)
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Event Date 02/18/2015 |
Event Type
Injury
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2015-05149.It was reported the patient experienced a heart attack.Several days later the patient began to receive uncomfortable stimulation in unintended areas.Reprogramming was tried but did not provide the patient with effective therapy.X-rays were taken and revealed the patient's lead placed on the left has migrated.A ct scan will be performed to further examine the lead location.The patient may undergo surgical intervention once he can overcome his unrelated health issues.Both of the patient's leads are being reported because it is unknown which lead has migrated.
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Manufacturer Narrative
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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#: 1627487-2015-05149.Reference mfr.Report#: 1627487-2016-03336.Reference mfr.Report#: 1627487-2016-03337.Follow-up revealed the patient under went surgical intervention on (b)(6) 2016.During the procedure, the patient's left lead was found to not be completely secured at the anchor site.In turn, the left lead was repositioned and the anchor was left as is.Surgical intervention resolved the patient's issue.Note: both of the patient's anchors are being reported because it is unknown which anchor is associated with the patient's left lead.
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Search Alerts/Recalls
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