Model Number SC-2317-50 |
Device Problems
Kinked (1339); Mechanical Problem (1384); Migration or Expulsion of Device (1395)
|
Patient Problems
Pain (1994); Inadequate Pain Relief (2388)
|
Event Date 11/16/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional suspect medical device component involved in the event: model#: sc-2317-50 serial#: (b)(4) description: infiniontm cx 50 cm lead.
|
|
Event Description
|
A report was received that the patient was experiencing worsening pain on the left side traveling down the left leg due to lead migration.X-ray showed epidural stimulator leads project over the posterior spinal canal extending from the t7 level.It was also reported that the patient was having mechanical complications of the lead.The patient will undergo a lead revision procedure.
|
|
Manufacturer Narrative
|
Additional information was received that the reason for revision was the patient not getting adequate coverage due to lead migration.
|
|
Event Description
|
A report was received that the patient was experiencing worsening pain on the left side traveling down the left leg due to lead migration.X-ray showed epidural stimulator leads project over the posterior spinal canal extending from the t7 level.It was also reported that the patient was having mechanical complications of the lead.The patient will undergo a lead revision procedure.
|
|
Manufacturer Narrative
|
Additional information was received that the patient underwent a revision procedure wherein the lead was replaced.Device malfunction was suspected this was not due to manufactures air somehow, the lead was kinked any impedances occurred.The patient was doing well postoperatively.The explanted device was not returned to bsn as it was kept by the medical facility.A review of the manufacturing documentation for the lead revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
|
|
Event Description
|
A report was received that the patient was experiencing worsening pain on the left side traveling down the left leg due to lead migration.X-ray showed epidural stimulator leads project over the posterior spinal canal extending from the t7 level.It was also reported that the patient was having mechanical complications of the lead.The patient will undergo a lead revision procedure.
|
|
Search Alerts/Recalls
|