Model Number DB-1110C |
Device Problem
Premature Discharge of Battery (1057)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/22/2016 |
Event Type
malfunction
|
Event Description
|
A report was received that the patient was experiencing premature battery depletion after a non-device related hospitalization.The patient had to frequently charge the ipg and as a result the physician elected to replace the ipg.The patient was doing well post-operatively.
|
|
Manufacturer Narrative
|
Analysis of ipg db-1110c (s/n (b)(4)) revealed that the complaint of fast battery depletion was confirmed.Upon receipt the device would not be charged nor linked to a test remote control even after two charging attempts.The device was cut open, and the battery measured volts.The device exhibited excessive sleep current leakage and the impedance between vh and ground was low.The source of the device damage was the monopolar electrocautery used to reopen the ipg pocket as stated in the complaint.Electrocautery can transfer destructive current into the dbs leads and/or stimulator (physician¿s manual (b)(4)).
|
|
Event Description
|
A report was received that the patient was experiencing premature battery depletion after a non-device related hospitalization.The patient had to frequently charge the ipg and as a result the physician elected to replace the ipg.The patient was doing well post-operatively.
|
|
Search Alerts/Recalls
|