Model Number 3660 |
Device Problems
Device Inoperable (1663); Communication or Transmission Problem (2896)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 12/11/2015 |
Event Type
Injury
|
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.(b)(4).
|
|
Event Description
|
It was reported the patient's ipg would not communicate with the clinician programmer.An sjm representative attempted to establish communication for approximately an hour to no avail.As a result, surgical intervention took place on (b)(6) 2015 at which time the patient's ipg was explanted and replaced.Effective therapy and communication were reportedly restored postoperative.
|
|
Manufacturer Narrative
|
The capa was initiated on 2016-02-23 to address the issue in which the ipg experienced loss of power, causing the patient to lose pain relief requiring replacement of the device.Investigation is currently in progress.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.
|
|
Manufacturer Narrative
|
The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.Corrected data: device code & results.
|
|
Search Alerts/Recalls
|