|
Model Number 977A260 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Cerebrospinal Fluid Leakage (1772); Spinal Cord Injury (2432)
|
Event Date 02/04/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical products: product id: 977a260, serial#: (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that during lead implant there was an intrathecal puncture.Environmental/external/patient factors that may have led or contributed to the issue were difficult visualization of anatomical structures. the physician preformed a blood patch procedure to prevent post procedure headache and csf leak. the issue was resolved.Hcp had no further information.
|
|
Search Alerts/Recalls
|
|
|