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

Model Number 97702

Device Problems Break (1069); Degraded (1153); Failure to Deliver Energy (1211); Unintended Collision (1429); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: neu_ins_stimulator, implanted: (b)(6) 2009, product type: implantable neurostimulator.

Event Description

Information was received from a consumer regarding an implantable neurostimulator (ins).It was reported that the patient had a loss of therapy.The patient stated that they have moved and have not adjusted their battery.Patient services verified and the caller stated that they are having issues trying to turn stimulation up after they charge the device.The patient further stated that when they go to turn stimulation up it seems like it "backfires" and shoots back.Patient services reviewed and the patient confirmed using the patient programmer that stimulation was on and the patient is using program a.Patient services reviewed and patient was able to increase stimulation, but noted that the stimulation shot towards their back.The patient stated that it is the highest they can increase stimulation without the spiking feeling.Patient services reviewed and the patient decreased stimulation to a comfortable level and stat stimulation is now tolerable.The patient stated that they cannot get pain relief because they cannot turn stimulation high enough without feeling the spiking.The patient was on program 1 at 1.3 volts.Patient services reviewed and patient changed to program 2 and confirmed.6 volts and stated that they do not feel stimulation.The patient increased stimulation on program 2 and stated that they are feeling stimulation but seemed like it was coming from their other implant battery which is like a pacemaker battery.The patient stated that they were feeling stimulation coming from their battery at the time of the call when they changed program 2 and increased stimulation.Patient services verified and the patient noted that program 1 is the setting programmed for their left side.It was reviewed to decrease the setting they were on and to follow-up with the healthcare provider (hcp) to check the device.The patient reported that they fell and broke their arm in november 20126 and they are having issues doing anything.The fall was unrelated to the device and therapy, but since the fall they have been having the issuestrying to turn stimulation up and down.The patient can change stimulation.The patient stated that changing the remote control settings helped, but they can't turn it up enough without spiking and cross firing to relieve the low back pain.The patient stated that the issue has not been resolved.The patient needs to keep the device below 2.2 or they get the spiking, and if it gets any higher the device cross-fires.The patient stated that they have to turn the device almost off to run the charger.Even then they have to be on their feet to charge.When the patient sits down it feels like a crossfire from the left to right battery with spiking in their left side.No further complications were reported.

Manufacturer Narrative

Correction as (b)(4) was not meant to be coded in fdd's.

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

The patient stated that they were responding to a letter they received.The patient stated that they never got and id card for their new ins.The patient stated that they were about 185-190 pounds at the time of the event.The patient stated that they had moved and they still don't have a managing physician and they are waiting for their medical records being released.

Manufacturer Narrative

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

Manufacturer Narrative

Product id: neu_unknown_lead, serial# unknown, product type lead; product id: neu_ins_stimulator, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2014, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.The patient reported that she had a fall ¿and then i found that i was cross firing with the leads and i met with a manufacturer¿s representative (rep) last month and we found i had damaged the leads in the fall, so they had to disconnect the electrodes and then reprogram my unit, that was just like last month.¿ the patient reported that the fall was actually 2-3 years ago.No further complications were reported.

Manufacturer Narrative

Correction: device information updated/corrected.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient on (b)(6) 2019.They reported that they were still having the same issues with their ins pertaining to the stimulation "cross firing" and causing a shocking sensation in their hip.A request was made to meet with a manufacturer representative (rep) to check the device.They were redirected to their doctor to request an appointment be set up to meet with a rep.Physician listings were sent to the patient since they reported they did not currently have a doctor managing their device.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 received stated that the cause of the "cross firing" and shocking sensation the patient was feeling when the stimulation settings was greater than 2.2 was that several contacts were bent.The patient stated the ins was reprogrammed to not use the damaged contacts.Additional information received clarified that the cause was a fall the patient had, where they "broke femor bone in left arm" and their back hit a chair as they fell.The patient stated their programmer was not able to program the ins to mri mode.The patient stated that the mri was needed to diagnose the severe pain which the ins was not able to relieve.The patient stated they have severe pain when transitioning from sitting to standing, but their pain then goes from a 10 to a 5.The patient had stated therapy on her neck to help with the neck pain.The patient was told her muscles were "jammed up into her skull" and were pressing on nerves.The patient planned to have therapy on her back later.There were no reported complications and no further complications were expected.

• 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 MN 00777 1200
• MDR Report Key: 6425388
• MDR Text Key: 70713179
• Report Number: 3007566237-2017-01081
• Device Sequence Number: 1
• Product Code: LGW
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 90