Model Number 37603 |
Device Problem
Low impedance (2285)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
A manufacturer representative (rep) reported that the patient is showing a low impedance on their left implantable neurostimulator (ins).Impedances for 0 and 1 were shown to be 33 ohms, with all other pairs within acceptable ranges.There were no patient symptoms alleged and follow up is being performed to obtain further information.Indication for implant is dystonia.
|
|
Event Description
|
Additional information was received from a manufacturer representative (rep).It was reported that the cause and the date of when the low impedances began occurring was unknown.It was noted, however, that they began occurring during the post-operative period.It was also unknown if the patient experience any symptoms associated with the issue.The rep stated that the actions/interventions taken to resolve the low impedances included programming around the low impedance pair.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|