Model Number NEU_ENTERRA_INS |
Device Problems
High impedance (1291); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/09/2014 |
Event Type
Injury
|
Manufacturer Narrative
|
The main component of the system and other applicable components are: product id: neu_unknown_lead, product type: lead.If information is provided in the future, a supplemental report will be issued.[mw5073611.Pdf].
|
|
Event Description
|
The healthcare provider (hcp) reported via the user facility that the implant was replaced due to high impedance on (b)(6) 2014.The impedance was noted above 1000.There was a revision of the device due to malfunction in 2014.The patient outcome was hospitalization.There were no further complications reported as a result of this event.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|