MAUDE Adverse Event Report: NUVECTRA CORPORATION ALGOVITA-SPINAL CORD STIMULATION; STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF), PRODUCT CODE: LGW

Model Number	2412
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2015, it was reported that the patient's generator 03edfa runs out of power within 20 hours.Charging procedure takes 4 hours.On (b)(6) 2016, it was reported that the patient's generator 03edfa runs out of power within 6 hours from 4/4 to 0/4 bars of charging indicator.It takes minimum 4 hours to charge patients ipg [generator] from 0/4 to 4/4 bars.During charging procedure stimulation is switched off.Additionally, the ppc [patient programmer charger] runs out of power before ipg is fully charged.The patient was able to fully charge the ipg with the new ppc.On (b)(6) 2016, it was reported that the patients generator 03edfa was explanted.Patient received a replacement device.Patient follow-up indicates they are receiving ons stimulation as intended.
Additional Manufacturer Narrative
(b)(4).Follow-up 01: device 03edfa was received in apparently good physical condition with an operable telemetry radio.This device has provided telemetry data for inspection.The inspection of this data is ongoing; further test operations for this ipg will be determined after inspection of the uplinked telemetry data is complete.
Event or Problem Description
On (b)(6) 2015, it was reported that the patient's generator 03edfa runs out of power within 20 hours.Charging procedure takes 4 hours.On (b)(6) 2016, it was reported that the patient's generator 03edfa runs out of power within 6 hours from 4/4 to 0/4 bars of charging indicator.It takes minimum 4 hours to charge patients ipg [generator] from 0/4 to 4/4 bars.During charging procedure stimulation is switched off.Additionally, the ppc [patient programmer charger] runs out of power before ipg is fully charged.The patient was able to fully charge the ipg with the new ppc.On (b)(6) 2016, it was reported that the patients generator 03edfa was explanted.Patient received a replacement device.Patient follow-up indicates they are receiving ons stimulation as intended.
Additional Manufacturer Narrative
Date of this report 01/05/2017 updated to 02/02/2017.Date received by manufacturer, (b)(6) 2016, removed.Investigation is ongoing.Device presently being characterized for the condition reported in the patient complaint.
Event or Problem Description
On april 2nd, 2015, it was reported that the patient's generator 03edfa runs out of power within 20 hours.Charging procedure takes 4 hours.On april 31st, 2016, it was reported that the patient's generator 03edfa runs out of power within 6 hours from 4/4 to 0/4 bars of charging indicator.It takes minimum 4 hours to charge patients ipg [generator] from 0/4 to 4/4 bars.During charging procedure stimulation is switched off.Additionally, the ppc [patient programmer charger] runs out of power before ipg is fully charged.The patient was able to fully charge the ipg with the new ppc.On (b)(6) 2016, it was reported that the patients generator 03edfa was explanted.Patient received a replacement device.Patient follow-up indicates they are receiving ons stimulation as intended.
Additional Manufacturer Narrative
Battery recharge time was found to be within normal expectations.No unexpected energy loss was observed in idle mode or storage mode operations.Stimulation run time was found to be much shorter than expected for the conditions of the patient program under test.Destructive analysis to be performed.
Event or Problem Description
On april 2nd, 2015, it was reported that the patient's generator 03edfa runs out of power within 20 hours.Charging procedure takes 4 hours.On april 31st, 2016, it was reported that the patient's generator 03edfa runs out of power within 6 hours from 4/4 to 0/4 bars of charging indicator.It takes minimum 4 hours to charge patients ipg [generator] from 0/4 to 4/4 bars.During charging procedure stimulation is switched off.Additionally, the ppc [patient programmer charger] runs out of power before ipg is fully charged.The patient was able to fully charge the ipg with the new ppc.On (b)(6) 2016, it was reported that the patients generator 03edfa was explanted.Patient received a replacement device.Patient follow-up indicates they are receiving ons stimulation as intended.
Additional Manufacturer Narrative
The returned stimulator was received in good physical condition macroscopically.Electrical analysis of the explanted stimulator identified an anomaly in the stimulation asic resulting in an elevated current draw, leading to reduced operational run time.The device history record was reviewed with no issues identified.During manufacturing, the board level test and the device final functional test met all requirements.An analysis of the lot and associated subassemblies did not identify anomalies.There is no trend regarding this failure mode and nuvectra will continue to monitor for similar events.The cause of the original electrical anomaly is unknown.

• Brand Name: ALGOVITA-SPINAL CORD STIMULATION
• Common Device Name: STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF), PRODUCT CODE: LGW
• Manufacturer (Section D): NUVECTRA CORPORATION; 10675 naples street ne; blaine 55499
• MDR Report Key: 6156884
• Report Number: 3010309840-2016-00013
• Device Sequence Number: 720737
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P130028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 12/16/2016
• Device Model Number: 2412
• Device Catalogue Number: 2412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/08/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 01/05/2017; 02/02/2017; 03/06/2017; 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR