Model Number MN10450-50A |
Device Problems
Therapy Delivered to Incorrect Body Area (1508); Therapeutic or Diagnostic Output Failure (3023)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 12/19/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
Related manufacturer reference number: 1627487-2020-00225.It was reported that patient¿s l3 (serial number (b)(4) lead had constant impedance changes from normal to high and low impedances.Patient also experienced ineffective stimulation from the l4 (serial number (b)(4) lead.In turn, surgical intervention took place on (b)(6) 2019 wherein the leads were explanted and replaced with new leads addressing the issue.The l3 lead was noted to be fractured at explant.
|
|
Manufacturer Narrative
|
It was inadvertently reported that the serial number for the l4 lead is (b)(4).The correct sn for this report s mentioned in the additional report-1.
|
|
Event Description
|
Additional information received indicates that the patient experienced stimulation in unwanted areas.Reportedly, therapy was resumed and issue was resolved post operatively.
|
|
Manufacturer Narrative
|
The reported event of ineffective stimulation was not confirmed.As received, visual inspection showed the returned lead (a) had a kink on the outer tubing.The lead passed end to end continuity test and lead wire to lead wire isolation test.The cause of the reported event remains unknown.
|
|
Search Alerts/Recalls
|