Model Number SC-2218-50 |
Device Problems
Bent (1059); Fracture (1260); Kinked (1339); Migration or Expulsion of Device (1395); Component Missing (2306)
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Patient Problem
Pain (1994)
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Event Date 12/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: model #: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator.
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Event Description
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A report was received that the ipg was pushing against the patients spine and was painful.The patient underwent a revision procedure wherein the ipg was relocated and then one of the patients lead was replaced due to lead fracture.Device malfunction was suspected of the explanted lead.The patient was doing well post operatively.
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Manufacturer Narrative
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Additional information was received that the physician removed the silicone material from the patients body during the revision procedure.
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Event Description
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A report was received that the ipg was pushing against the patients spine and was painful.The patient underwent a revision procedure wherein the ipg was relocated and then one of the patients lead was replaced due to lead fracture.Device malfunction was suspected of the explanted lead.The patient was doing well post operatively.
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Manufacturer Narrative
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A review of the manufacturing documentation for the products revealed that no anomalies or deviations potentially relate to the event occurred during the manufacturing.
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Event Description
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A report was received that the ipg was pushing against the patients spine and was painful.The patient underwent a revision procedure wherein the ipg was relocated and then one of the patients lead was replaced due to lead fracture.Device malfunction was suspected of the explanted lead.The patient was doing well post operatively.
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Manufacturer Narrative
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Sc-2218-50 (b)(4) device evaluation indicated that the lead complaint has been confirmed.Visual inspection found that the lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 24 cm from the distal end.X-ray inspection confirmed 6 cables were fractured (electrodes 1, 2, 4-7).There are no exposed cables at the clik site fracture.Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event.Sc-4316 (ln 17801468) device evaluation indicated that the clik anchor has torn eyelet with missing silicone material.
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Event Description
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A report was received that the ipg was pushing against the patients spine and was painful.The patient underwent a revision procedure wherein the ipg was relocated and then one of the patients lead was replaced due to lead fracture.Device malfunction was suspected of the explanted lead.The patient was doing well post operatively.
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Search Alerts/Recalls
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