Model Number 3086 |
Device Problems
Fracture (1260); Material Fragmentation (1261); Migration (4003)
|
Patient Problems
Inadequate Pain Relief (2388); Device Embedded In Tissue or Plaque (3165)
|
Event Date 03/12/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
"date of event: date of event" is estimated.During processing of this complaint, attempts were made to obtain complete event information.The results/method and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
Related manufacturer reference number: 3006705815-2020-01349.It was reported that one of the patient's leads came out of the patient completely.Another lead broke and came out of the patient partially while part of the lead remained in the spine.It is unknown if surgical intervention occurred to explant the part of the lead that remained in the spine.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|