Model Number 3772 |
Device Problem
Temperature Problem (3022)
|
Patient Problem
Burning Sensation (2146)
|
Event Date 01/22/2020 |
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
|
It was reported that the patient¿s ipg gets hot while recharging.In turn, surgical intervention may take place at a later date to address the issue.
|
|
Event Description
|
Additional information received indicates that only the ipg was explanted.The lead remains implanted.
|
|
Manufacturer Narrative
|
The reported event of ipg gets hot during recharge was not confirmed.The device was placed in a heated chamber and after several hours of recharge, the rise in temperature was within the product requirement specifications for heat generation during use.Also, the return ipg passed all functional testing at lab bench and onto the autotester.
|
|
Event Description
|
Additional information received indicates that that surgical intervention took place on (b)(6) 2020 wherein the ipg was explanted and replaced with a new ipg to address the issue.
|
|
Manufacturer Narrative
|
Date of event is estimated.
|
|
Event Description
|
Additional information received indicates that the physician decided to explant the entire system on (b)(6) 2020.The issue regarding ipg gets hot while recharging has been resolved.Therapy has been confirmed post operatively.
|
|
Search Alerts/Recalls
|