Model Number NEU_ENTERRA_INS |
Device Problem
Break (1069)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/14/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Information references the main component of the system and other applicable components are: product id 4351-35, serial# (b)(4), product type lead (b)(4) pertain to product id 4351-35 serial# (b)(4), product type lead.
|
|
Event Description
|
Information was received from a healthcare professional (hcp).It was reported that the device (lead) was broken during implant in the patient.No patient symptoms were reported.No further complications were reported/anticipated.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|