Model Number 3716 |
Device Problems
Use of Device Problem (1670); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 01/19/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
|
|
Event Description
|
Further follow up identified the patient has effective therapy postoperatively.
|
|
Manufacturer Narrative
|
Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
|
|
Event Description
|
It was reported, the patient was unable to establish communication between her ipg and external devices.A sjm representative confirmed the communication issue with multiple external devices.The patient never charged her ipg.The ipg was explanted and replaced (according to manufacturer device database).
|
|
Manufacturer Narrative
|
(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
|
|
Search Alerts/Recalls
|