Model Number 37612 |
Device Problems
Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896); Environmental Compatibility Problem (2929)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/25/2016 |
Event Type
Injury
|
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
|
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for dystonia and movement disorders.It was reported that the patient had a difficulty charging due the implant being too deep in the patient's right breast tissue.It was also noted that the issue occurred after the patient became pregnant two years ago.A revision surgery was performed on (b)(6) 2016 to move the implantable neurostimulator (ins) higher up in the patient's right chest as she was unable to achieve efficient coupling when recharging.Following the procedure, it was confirmed that all 8 coupling bars were achieved; the issue was resolved.There was no known impact or consequence to the patient.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|