ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
|
Back to Search Results |
|
Model Number 3186 |
Device Problem
Disconnection (1171)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 03/17/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
|
|
Event Description
|
Related manufacturer reference number 1627487-2021-12883, 3006705815-2021-01536.It was reported that one of the patient's leads pulled out from the ipg after patient had a fall.The lead pullout was confirmed via x-rays.Surgery took place on (b)(6) 2021 wherein the pulled lead was repositioned back into the ipg.It is not known which lead pulled out from ipg, so both leads are being reported.During the procedure, the ipg header broke while lead was being put back into the ipg.As a result, the ipg was also explanted and replaced.
|
|
Search Alerts/Recalls
|
|
|