|
Model Number 103 |
Device Problems
Energy Output Problem (1431); Unexpected Therapeutic Results (1631); Device Displays Incorrect Message (2591)
|
Patient Problems
Seizures (2063); Therapeutic Response, Decreased (2271)
|
Event Date 11/16/2016 |
Event Type
malfunction
|
Event Description
|
The physician reported seeing a message indicating that the patient was not receiving the intended output current from his generator.Diagnostics were available from the patient¿s (b)(6) visit and show that the results were with in normal limits.Recently the patient had been experiencing an increase in seizures that the physician attributes to lower than programmed output current being delivered.Using ohms law, it was found that the generator should be able to deliver 3.125ma, which is well above the programmed 2ma the patient's generator was set to.No other relevant information has been received.
|
|
Event Description
|
High impedance was previously observed with the same generator and lead.Patient underwent explorative surgery in 2013, when the surgeon found that the lead and generator were twisted.After untwisting the leads the surgeon performed system diagnostics and saw that the patient¿s lead impedance was within normal limits.The devices were not replaced as a result.The high impedance and explorative surgery was previously reported in mfr.Report # 1644487-2013-00040.Intermittent high impedance was observed as the devices were not replaced, which can prevent the patient from receiving the intended output current from the generator.This may have contributed to the low output current warning the physician observed.Any further relevant information regarding the high impedance and low output current will be reported in mfr.Report # 1644487-2013-00040.
|
|
Search Alerts/Recalls
|
|
|