Model Number 3186 |
Device Problems
Use of Device Problem (1670); Material Split, Cut or Torn (4008)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with the investigation results will be provided in the final report.
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Event Description
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Device 2 of 2.Reference mfr.Report#: 3006705815-2020-02587.It was reported the patient underwent surgical intervention for an issue reported under mfr report#: 3006705815-2020-02583 and 3006705815-2020-02584.During surgical intervention, one of the patient's leads was cut accidentally by the physician when they attempted to relocate both of the patient's leads.In turn, the physician decided to remove the portion of the lead that was cut and left the remaining portion of the lead in the patient.Both of the patient's leads are being reported because it's unknown which lead was cut by the physician.
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Manufacturer Narrative
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Corrected data: h6 - device code.The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted system.
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Event Description
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Device 2 of 2 reference mfr.Report#: 3006705815-2020-02587.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Additional information received indicates the partial lead was explanted.
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Search Alerts/Recalls
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