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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330); Electric Shock (2554)

Event Date 10/23/2017

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 manufacturer representative (rep) via a patient with an implantable neurostimulator (ins) for spinal pain and lumbar radiculopathy.The patient called the rep on the night of (b)(6) 2017 and stated that they have extreme buzzing down their legs that is uncomfortable.The device was decreased to 0 and turned off but it has not gone away.The rep noted that the patient had an mri but it was on label.The rep would meet with the patient.Technical services reviewed that the rep should try to perform a short physician reset mode (prm).No further complications were reported/are anticipated.

Manufacturer Narrative

Analysis of the ins (serial# (b)(4)) found that the ins was functionally okay with insignificant anomalies.The 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 all electrode pairs referenced to the {referencing to the #0 and #8 electrodes} electrode.Analysis determined there were no issues when pressing on the ins can.The ins was recharged at room temperature with 1 cm spacing between the recharger antenna and the ins and no issue was observed.The ins was recharged at room temperature with 1 cm spacing between the recharger antenna and the ins and no coupling issues were observed.Analysis determined the telemetry was acceptable.Due to the reported complaint, the ins was put through a long-term monitor test and functioned without issue throughout 100 hours of testing at body temperature.Information references the main component of the system and other applicable components are: product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260 ,serial# va0nxl6005, implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Other applicable components are: product id: 97740, (b)(4), product type :programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacture representative (rep) on 2017-nov-09.The rep was not able to determine the cause of the patient feeling stimulation even with it at 0.0 volts and the patient programmer showing that it was off.They would be seeing the patient tomorrow.Additional information was received from the rep on 2017-nov-10.The rep was with the patient.They obtained the tni code.There was only one code before it showed lcc.That code was 523.The rep states that the patient has not touched or turned on the stimulation since halloween because they do not want to not be able to turn it off.The rep would get the file and session report and email later.No further complications were reported/are anticipated.

Manufacturer Narrative

Other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacture representative (rep) on 2017-nov-22.The rep stated that the stimulation not turning off problem has occurred again.Technical services had the rep try a short physician reset mode (pmr) and the patient reported it did not turn the implantable neurostimulator (ins) off.The rep reported that the physician programmer indicated that the stimulation was off.The rep would have the doctor check with an ekg to see if the stimulation was off.No further complications were reported/are anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacture representative (rep) on 2017-dec-05 indicating that they were aware of information on 2017 (b)(6).The rep indicated that the ekg showed that the stimulation was on even though they tried multiple times to reset per technical services direction.The patient was so uncomfortable that the healthcare professional (hcp) removed the device on 2017 (b)(6) around 5:30pm.The rep indicated that they let technical services know that it was going to happen because nothing else was working.The patient felt immediately better after the device was removed.The rep sent the device back for analysis.The patient was implanted on 2017 (b)(6) and is doing well.Additional information was received from the patient on 2017 (b)(6).The patient was complaining of the battery turning on by itself and surging.They did an ekg at the hcp office and the device was on.They tried resetting several times with the recharger but nothing worked.The doctor explanted the device.The device would not shut off per the recharger or programmer.The device was removed and the patient recovered without sequela.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacture representative (rep) on 2017-oct-28.The rep indicated that the cause of the buzzing was not determined.The patient¿s device was turned off at 3pm per their telemetry reading and the patient called the rep at 7:30pm that evening.The issue was resolved.Additional information was received from the rep on 2017 (b)(6) indicating that the patient states the same situation is still happening.Technical services reviewed the possible use of an ekg to confirm that the stimulation was off and doing a physician mode reset (pmr).Additional information was received from the rep on 2017 (b)(6).The patient went to the emergency room (er) and they saw stimulation pulses on the ekg.The doctor used the clinician programmer and turned the implantable neurostimulator (ins) off and the patient reported that the stimulation stopped.The rep would meet with the patient and capture the diagnostics if the issue occurs again.The rep mentioned that the doctor may just replace the ins.Additional information was received from the rep on 2017 (b)(6).The issue is still occurring with the replacement patient programmer that was sent to the patient and with the patient¿s recharger.The patient did sync up with the patient programmer.They felt stimulation event at 0.0 volts.Only the clinician programmer was able to turn it off even though the patient programmer showed that it was off.The rep did try a short pmr but it did not power on reset (por) the device.The rep used the patient programmer in the office with the patient on the day of the report and could not replicate the issue.It went on and off and the patient¿s sensations started and stopped in correlation with the patient programmer.The rep sent in a diagnostic report of the patient¿s device.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer.It was reported that the patient could not turn off stimulation and was experiencing electrical shocking and that was the reason for replacement.

• 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
• 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: 6980182
• MDR Text Key: 90852653
• Report Number: 3004209178-2017-22575
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/31/2018

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: 08/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 10/28/2017; 11/09/2017; 11/22/2017; 11/22/2017; 01/12/2018; 03/27/2018
• Supplement Dates FDA Received: 11/08/2017; 11/21/2017; 12/05/2017; 12/18/2017; 01/17/2018; 03/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2014
• 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: 63 YR