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

Model Number 97714

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 977c265, lot# va1a0bn018, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.

Event Description

A patient reported via manufacturer representative that they were having problems with their implantable neurostimulator (ins).The patient met with a manufacturer representative on (b)(6) 2017 for adjustments and reprogramming.They were reprogrammed to better cover the pain area, adjusted the pulse, changed the handheld device so that they only use #1 to adjust stimulation and they asked to have the positional stimulation turned on.At that time, the patient was experiencing increasing stimulation at times without even moving.They were told that they were still early in the process and the leads were not yet scarred in.The patient reported that they were happy at that time.However, the increase in stimulation when not moving had become very painful jolts.They were experiencing frequent jolts, down their leg or across their hips, with no movement that took their breath away.They were also experiencing periods of no stimulation, with no movement.It seems as if everything is fine and then suddenly jolts back to stimulation, to nothing, to stimulation, all within a 30 second to a few minutes¿ periods.It gets painful and they have to turn it off.They tried keeping the stimulation at a low setting.They keep the stimulation set at 3.20 or so.They don¿t have the horrible jolts, but their pain is not covered either.They wanted to get the positional feature turned off.Reprogramming was planned for the following week.The indication for implant was unknown.

Manufacturer Narrative

Other applicable components are: product id: 977c265, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.

Event Description

Additional information was received from the manufacturing representative reporting that impedances were checked today on the patient¿s device and all were normal and the implant was on.It was reported that the patient was told to turn their ins off last week.They did not have any shocking when the stimulation was off.It was reported that the shocking was not related to positional movement.The patient experienced the shocking/surging sensation on the left side and down their leg without moving.It was reported that they were able to program around the discovered issue and that the patient was receiving therapy benefits.The patient was programmed at 0-, 1-, 2+, 3+- and it was recommended having one of the cathodes removed.It was reported that the event occurred in (b)(6) 2016, since the patient was implanted, however it was also reported that it had gotten worse in the last month.

Manufacturer Narrative

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 from a manufacturer representative on (b)(6) 2017 reporting that another manufacturer representative met with the patient for reprogramming and the jolting problem resolved.The patient left the reprogramming happy.The jolting was resolved by separating the cathodes from the original programming.The reporting manufacturer representative was contacted by the patient earlier that week for another reprogramming.The patient described the event as the stimulation acting as if it was coming on and off.The reporting manufacturer representative was meeting with the patient later on the day of the report (b)(6) 2017.

Manufacturer Narrative

Concomitant medical products: product id: 977c265, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 977c265, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.

Event Description

Additional information was received from a manufacturing representative on (b)(6) 2017 reporting that an x-ray was taken and the patient's doctor said the leads were still in the same position as they were when they were implanted.It was reported that they were going to try and program hd on (b)(6) 2017 and see if that works.It was reported that if that does not help then the patient will be referred for a battery replacement.Pictures of the patient's x-rays were included.No further complications were reported/anticipated.On (b)(6) 2017, additional information was received indicating that the ins was turned on in (b)(6) after the procedure, which is when the issues started with the surging/stimulation cutting out.It was mentioned the delay in turning the device on may have been due to difficulty of the case.It was reported that the patient felt surging down their legs when it occurred and they would lose coverage in areas of pain when it would cut out.It was confirmed that the patient checked the ins with their patient programmer (pp) and the voltage was the same, the ins was still on when the patient perceived the stimulation cutting off and surging.It was reported that when the system was functioning, the coverage was great.It was reported x-rays were done about 10 days ago and everything appeared to be lined up in the header block and the leads appeared to not have migrated.The impedances continued to be normal at.7 and 1.5v and the patient could recreate the sensation if they pushed on the ins.The caller stated that they tried to check impedances with the patient pressing on the ins, but at that time the sensation couldn¿t be replicated so impedances remained unchanged.It was reported that the patient felt the sensation constantly, but that they could also sometimes recreate it by pressing on their ins.It was reported that the patient was given hd program to try, but their physician requested engineering input on the situation first, before taking the patient back to the operating room to explore surgically.The patient had not been back to see the surgeon at all.It was suggested to try and capture impedances when the sensation was occurring and discussed the possibility of ¿fluid short¿.It was reviewed to reach out to colleagues before discussing with the engineers for other ideas.No further complications were reported/anticipated.

Manufacturer Narrative

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 from a manufacturer representative (rep).It was reported that the rep believed that several different programming options were tried in the past and the high density program that the rep gave the patient on (b)(6) 2017 made the patient feel like they had worms and ants crawling on their feet even when they turned it down.The rep had the patient switch back to group a and turn voltage up from 2.0 to 3.6 volts.The patient claimed that with amplitude turned up they were still able to create a bumping or stuttering sensation whenever they pushed on any part of the ins, and it would still randomly surge.The issue had not gotten better or worse since (b)(6) 2017.The patient continued to get great coverage when the device was working but they were bedridden due to pain because they couldn¿t turn stimulation up high enough to get pain relief because they felt the surging sensations.It was noted that the lead was about over ¿8/9 interspace¿ and just barely reached ¿9/10 interspace.¿ the patient had an appointment with a surgeon on (b)(6) 2017 and a rep would try to be there to capture impedance.

Manufacturer Narrative

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 from a manufacturer representative on 2017-04-17 reporting that the patient was able to cause the stimulation to ¿surge¿ and ¿cut in and out¿ by pressing on any edge of the battery.The manufacturer representative tried to capture an impedance measurement while this was happening but all results appeared to be within normal limits.It was reported that there was telemetry for when the representative saw the patient on (b)(6) 2017 and they attempted hd which was not successful on (b)(6) 2017 when they tried to get an imprudence measurement while the patient was pressing on the battery.The patient had a surgical consult and a battery replacement and possible lead revision was scheduled for (b)(6) 2017.The battery would be sent back for analysis at that time.No further complications were reported.

Manufacturer Narrative

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 from a manufacturer representative on (b)(6) 2017 reporting that the patient was having surgery on (b)(6) 2017.The patient saw the surgeon and had reached the point of trying everything so it was believed that there may be an issue with the header block.It was reported that they planned to test the leads with the multi-lead trialing cable (mltc) but would likely end up replacing the implantable neurostimulator (ins).It was reported that the explanted device would be returned for analysis.No further complications were reported.

Manufacturer Narrative

A supplemental report will be sent when device evaluation is complete.The conclusion code no longer applies.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.

Manufacturer Narrative

Other applicable components are: product id 977c265 lot# va1a0bn018 serial# (b)(4) implanted: (b)(6)2016 product type lead product id 977c265 lot# va1a0bn018 serial# (b)(4) implanted: (b)(6)2016 product type lead analysis of the implantable neurostimulator ((b)(4) ) found that the ins was functionally okay, with no significant anomaly.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6404004
• MDR Text Key: 69916453
• Report Number: 3004209178-2017-05579
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/25/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/14/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; 07/24/2017; 07/24/2017; 07/24/2017
• Supplement Dates FDA Received: 03/17/2017; 04/06/2017; 04/11/2017; 04/17/2017; 04/24/2017; 05/05/2017; 05/23/2017; 07/25/2017; 10/02/2017; 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR