It was reported that there was a possible problem with the implantable neurostimulator (ins).It was noted that the implantable neurostimulator (ins) depletion was being reported as premature.It was noted the last visit in (b)(6) of 2013, both batteries were >2.90.It was noted that on the date of report the right ins was 2.95 and the left ins was 2.63.It was further noted that the settings of the left ins were ¿strange¿ at 0- ,1-,2+,3+; ¿2.0/90/180.¿ it was noted that impedance was 1097 with a current of 1.848.It was noted that a longevity calculation was run with a result of 5-6 years.It was further noted that this only took into account impedance and not configuration.Additionally, it was noted that when an impedance check was done the healthcare professional (hcp) received a message stating that the amplitude delivered might be lower than intended (or something like that) and the hcp should consider reducing the voltage or lowering number of active contacts.It was noted that it made no sense to the hcp.The hcp attempted re-measuring and planned to take a photo but every subsequent measurement went through fine without the error message.It was noted that the hcp did a full impedance check and no problems were found.It was noted that the manufacturer representative conducted another longevity check at the same settings with the result of 5.46 years to elective replacement indicator (eri) and 5.71 years to end of service (eos).The manufacturer representative would look at past records for higher settings that may have caused the issue or any impedance data reflecting low impedance or shorts in the past.It was noted that it may have been an intermittent short.It was not known if the patient had any symptoms return in the past.Additional information received reported that the manufacturer representative left a message for the hcp to give a call and discuss the patient settings and whether or not there were any other issues.It was noted that the manufacturer representative had not heard back from the hcp.It was noted that per manufacturer's device registration, the device was explanted (b)(6) 2014.
|
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3389-40, lot# j0222859v, implanted: (b)(6) 2002,product type: lead.Product id: 3389-40, lot# j0222859v, implanted: (b)(6) 2002, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension.(b)(4).
|