MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97702

Device Problems Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Application Program Problem (2880); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient was "losing a minute per week" with their therapy since the last time they had it programmed- their device was set to run from 7 a.M.To 7 p.M.Daily in order to save on their battery life.Over time the device was running at 6:59, then 6:58, etc.Today they stated it was at 6:52 p.M.The representative was walked through updating the device after ensuring that their clinician programmer's time was correct and synced with the patient.The patient also reported having problems with their therapy since it was implanted.No further complications reported.Additional information received from the consumer reported that prior to resetting the device the manufacturer¿s representative (rep) reset the time at 7-7 p.M.And within six months the time was 6:52-6:52 p.M.The consumer didn¿t know what caused the issue to occur but after having it changed back to 7-7 p.M.There had been no time loss as of (b)(6) 2018.No further complications were anticipated.Additional information was received from the consumer.It was reported that therapy was turning on and off by itself.Patient reported he had scheduled therapy programmed to turn on at 7am and off at 7pm, however, he has been gradually losing minutes.Patient reported it's now turning off at 6:52 which wakes the patient up earlier than desired in the morning.Patient stated he has this problem in the past and had reprogramming done by the rep to address this issue.After the last time he had programmed he started to lose minutes again gradually.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative (rep) 2019-04-22.It was reported the scheduled therapy was losing time.The patient was scheduled for 7-7 but notices a change in time a 6:51.It was reviewed that the ins does not have a clock and therefore knows the time from the clinician programmer.Upon update on date of call, it would match the time on the clinician programmer, which was correct.No patient symptoms were reported.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the rep indicated that the ins is set to turn on at 8:00am but the time is ¿creeping up.¿ the rep stated that the stimulation turns on just slightly ahead of 8:00am.They indicated that the clock on the clinician programmer is correct.The rep mentioned that the clinician programmer shows that the scheduled therapy shows on from 08h-20h.They noted that the observation section on the clinician programmer showed that the ins time had changed since the last session, and that the device time was 3 minutes fast.The rep corrected the time.No further complications were reported or anticipated.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a manufacturer representative from a consumer regarding the patient.It was reported that stimulation was still coming on at 51 minutes as apposed to on the hour.When meeting with the patient the manufacturer representative confirmed that they changed stimulation to come on from 8am to 8pm instead of 7am to 7pm and ensure that the time on the clinician programmer was correct but did not check the implantable neurostimulator time at all.At the time of the report, it was confirmed that the patient programmer was displaying 9:05am when it was actually 9:55am.The patient was able to set the clock to the right time to resolve the issue.There were no further complications reported or anticipated.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Additional information was received from the patient again reporting that their therapy was turning on and off by itself.It was reported that the patient was programmed with scheduled therapy and had noticed a discrepancy in time the ins was turning on and off following daylight savings time.The patient also reported the continuation of a separate issue of ¿losing time¿ that was previously reported.The patient noted that even after resetting the patient programmer clock with the rep back in jan/feb and working on the phone with patient services, the patient would notice gradual changes to the stimulation being on/off.They stated at first by only a minute or two and then progressively more and more.Currently the patient had therapy turned off at 5:47pm instead of 7:00pm (due to a combination of both issues).It was reported that the patient had been keeping a diary.It was reviewed screen navigation to access the patient programmer clock.It was reported the patient¿s current time was 6:01 pm and the current patient programmer time was 7:14 pm.It was reviewed how to change the time from 7 to 6 for daylight savings and how to change the minutes to reflect the current time.Patient services consulted technical services and reviewed that the clinician programmer clock was a factor if the ins had been interrogated.They reported to them that gradually their time moved earlier and earlier, starting with 1 to 2 minutes and progressing to 5 minutes and so on.Today there was a 1 hour and 13 minute discrepancy (due to day light savings).Aside from daylight savings there was a 13 minute discretion in time.The patient had never changed the programmer time on their own and they stated they used their cell phone to confirm the accurate time at their hcp visits.It was recommended that the patient keep a diary of the times stimulation was turning on/off daily.Additional information was received from technical services reporting that there was a factory calibration setting for the ins clock that the ins firmware automatically adds to its time-of day clock once every 24 hours to maintain a high accuracy clock.They stated that perhaps this value wasn¿t calculated and stored correctly in the ins during manufacturing or perhaps it got corrupted in sram after implant.They stated that they presume if this value was later corrupted in the eeprom (after implant) the patient would have seen a 575 error on the programmer if an eeprom reload took place.Technical services questioned how long the patient had been on scheduled therapy and whether their clock inaccuracy issue was always present.They stated a 5-second physician mode recharge(prm) por may be needed for a reload from eeprom in case the sram copy was corrupted.It was reported that this could also be done with a primary cell ins like the patient¿s.They suggested first turning on stimulation and then check that the stimulation was off after the prm por to make sure the reset command was executed by the ins.It was also questioned if the patient changed the ins time using the programmer and synced to download the change to the ins if they were able to get the ins clock and the scheduled therapy back on time.Technical service had reported that somewhere in the system specifications there was a tolerance for the ins time.They stated that they forget what it was, but they were thinking it was 15 minutes over one year if they recalled correctly.They questioned how long it took for the patient to have a 13 minute discrepancy and if any reset were done as time could be lost on resets.An outbound call was made to the patient and they confirmed whether the time updated on the patient programmer/ins, but it had not since the programmer was not synced after the time change during the call.Patient services rest the time again and confirmed it saved.It was reviewed that the patient¿s time change discrepancy was potentially within normal range and the patient stated that they would continue to keep a diary.The patient stated that they would work with their hcp to discuss closer to their next appointment which was in january.No symptoms were reported.The event occurred on (b)(6) 2018.No further complications were reported/anticipated.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7620587
• MDR Text Key: 112004388
• Report Number: 3004209178-2018-13880
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR