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

Model Number 97714

Device Problems Break (1069); Disconnection (1171); Failure to Deliver Energy (1211); High impedance (1291); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Malaise (2359); Confusion/ Disorientation (2553); Electric Shock (2554)

Event Date 11/14/2016

Event Type  Injury  

Event Description

A patient reported they were in a car accident yesterday; they were rear-ended.The patient was very confused because he was not feeling stimulation in the upper part of his back where he usually feels it.The patient was still feeling stimulation in his hips and legs where he normally feels it.The patient stated that he was shaken up from the accident and he was not thinking straight and he wasnt feeling well.The patient was redirected to his healthcare provider.The indication for implant was lumbar radiculopathy and spinal pain.

Event Description

Additional information was received from a manufacturer representative on (b)(6) 2016.The patient reported a change of stimulation and requested to be reprogrammed.They patient could no longer feel stimulation in their back.There had been a motor vehicle accident last week.Impedances showed that the several electrodes >10,000 ohms.The out of range impedances were found on electrode 0, 1, 12, 13, 14, and 15 with the reference of electrode 2 and on all electrodes when using electrode 0 as a reference.Programming was attempted.The patient had adequate coverage in the left side of their lower back and both legs.The complaint was not being able to feel stimulation in their lower back and that the patient had been able to feel it there prior to the motor vehicle accident.The issue had not been resolved at the time of this report.

Event Description

Additional information was received from manufacturer representative.It was reported that an impedance check and reprogramming had been performed.

Manufacturer Narrative

Concomitant products: product id: 377845, lot# v009204, implanted: (b)(6) 2006, product type: lead.Product id: 377845, lot# v009203, implanted: (b)(6) 2006, product type: lead.

Event Description

Additional information was received from a consumer via a manufacturer representative (rep).It was reported that the patient was seen in (b)(6) 2016 for reprogramming due to the stimulation no longer in the correct area after the motor vehicle accident in (b)(6) 2016.The inappropriate stimulation was reported to the physician for a lead revision.The physician instructed the patient to request an evaluation appointment with a previous pain clinic physician who implanted the manufacturer¿s devices.Steps to refer the patient to the physician were not taken and the patient was told that medicare wouldn¿t pay for a revision.The rep was contacted by the patient¿s legal counsel who requested the rep¿s assistance in getting a referral from the physician for a revision.The legal counsel was referred to the manufacturer¿s legal department.The issue was not resolved as of (b)(6) 2017.No surgical intervention occurred or was planned.The patient was alive with no injury.

Manufacturer Narrative

Concomitant medical products: product id 377845, lot# v009204, implanted: (b)(6) 2006, product type: lead.Product id 377845, lot# v009203, implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: lead.Product id 3708140, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: extension.Product id 3708140, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: extension.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 the manufacturing representative reporting that the patient was schedule for a lead revision yesterday ((b)(6) 2017).It was reported that they met with the patient pre-operatively and ran impedance checks on all 16 electrodes and found that they were all out of range.The report was included with their follow-up information.It was reported that in the operating room, they disconnected the ins and the physician observed evidence of what they thought were ¿burn marks¿ between the electrodes that plugged into the ins header.The electrodes were tested from the patient¿s two extensions and those still showed out of range impedances on multiple contacts.It was reported that they decided to explant the indwelling octad leads and extensions and implant a new system.It was reported that this was successful and post-operative programming/interrogation revealed great paresthesia coverage and normal impedances.It was reported that the patient¿s explanted product was going to be sent back for analysis.

Manufacturer Narrative

Concomitant medical products: product id 377845, lot# v009204, implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: lead.Product id 377845, lot# v009203, implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: lead.Product id 3708140, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: extension.Product id 3708140, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: extension.Product id 3550-39, product type: accessory.Product id 3550-39, product type: accessory.The device was received on 2017-03-28 but analysis is not yet complete.A supplemental will be sent when analysis is complete.

Event Description

Additional information from the manufacturer representative on 2017-03-28 reported that the patient had a motor vehicle accident in (b)(6) 2016.The impedances were out and a lead revision was performed on (b)(6) 2018 which concluded with the leads and extensions not working properly.

Manufacturer Narrative

Other applicable components are: product id 377845 lot# v009204 implanted: (b)(6) 2006 explanted: (b)(6) 2017 product type lead product id 377845 lot# v009203 implanted: (b)(6) 2006 explanted: (b)(6) 2017 product type lead product id 3708140 serial# (b)(4) implanted: (b)(6) 2006 explanted: (b)(6) 2017 product type extension product id 3708140 serial# (b)(4) implanted: (b)(6) 2006 explanted: (b)(6) 2017 product type extension product id 3550-39 serial# unknown product type accessory product id 3550-39 serial# unknown product type accessory h3.Analysis of the lead v009204 found that the conductors on the lead body were broken at the titan anchor site.Conductors 0 and 1 were broken at 21.5 centimeters from the distal end.It was also found that at the proximal end of the lead body around all the connectors there was degraded insulation consistent with metal ion oxidation (mio).Functional test results circuit #0: open circuit #1: open circuit #2:5.7 ohms circuit #3: 4.1 ohms circuit #4: 4.3 ohms circuit #5: 5.4 ohms circuit # 6: 4.1 ohms circuit #7: 4.8 ohms there were no shorts between the circuits.Analysis of lead v009203 found that there was no significant anomaly and/or the device was damaged during explant.It was found that the stimulator lead body was cut through and the product was segmented.Analysis of extension njb004821n found that the outer insulation on the stimulator extension body had melted.It was found that there was setscrew impression on the insulation between connector 0 and 1.The degraded insulation was consistent with mio around all of the connectors.Analysis found that there was no significant anomaly and/or the device was damaged during explant.Analysis of extension njb000746v found that the outer insulation on the stimulator extension body had melted.It was found that the setscrew impression was too proximal.The degraded insulation was consistent with mio around all the connectors.Ananlysis found that there was no significant anomaly and/or the device was damaged during explant.H6.Evalution device method codes are all applied to all returned products.Evaluation device results codes are applied to the following device: lead v009204- 452 and 180 lead v009203- 452 and 213 extension njb004821n- 476 and 213 extension njb000746v- 476-213 evaluation device conclusion codes are applied to the following device: lead v009204- 67 lead v009203- 71 extension njb004821n- 71 extension njb000746v- 71.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

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

Device evaluation: analysis of the implantable neurostimulator (ins) found the ins was functionally okay with insignificant anomalies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient¿s legal counsel on 2017-jul-19 noted the patient¿s ins had ¿malfunctioned after he was injured in the wreck¿ and was replaced on(b)(6)2017 as a result.It was also reported that the patient was ¿told that several of the leads were broken.¿ it was noted that while the patient¿s device was very beneficial and significantly decreased his pain originally, the patient¿s pain had ¿increased greatly¿ following their car accident.The patient¿s pain was once again decreased following the replacement of the ins.

Manufacturer Narrative

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

Manufacturer Narrative

The implantable neurostimulator (ins) passed functional testing.The ins passed the final functional test on the automated test console.A lab functional test determined there was good stable output on the electrode pairs the ins had when it was received.A lab functional test determined there was good stable output on all electrode pairs.Analysis determined there were no issues when pressing on the ins can.Analysis determined the telemetry was acceptable.Concomitant medical products: product id: 377845, lot# v009204, implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: lead.Product id: 377845, lot# v009203, implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: lead.Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2017, product type: extension product id 3708140 lot# serial# njb000746v implanted: 2006-08-04 explanted: (b)(6) 2017, product type: extension.Product id: 3550-39 , serial# unknown, product type: accessory.Product id: 3550-39, serial# unknown, product type: accessory.Product id: 37711, serial# (b)(4), implanted: (b)(6)2006, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a275, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 97714, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.Product id: 977a275, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.It was reported that the car accident had caused the leads to get pulled from the ins.The patient reiterated that after the accident, they were shocked when they turned the stimulation on.No further complications are anticipated.

• 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: 6106946
• MDR Text Key: 60039936
• Report Number: 3004209178-2016-24171
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2015
• 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: 48 YR