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

Model Number 97702

Device Problems Failure to Deliver Energy (1211); Overheating of Device (1437)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Sleep Dysfunction (2517)

Event Date 08/20/2020

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).It was reported that in (b)(6) 2020, the patient started having issues with their stimulator, which was explained to mean that they could still feel stimulation down their left leg but could no longer feel stimulation down their right leg.They also reported feeling a burning sensation at the ins site, which hurts more when they are sitting.They also couldn't lay down on the ins.The patient confirmed they didn't have any falls or trauma that could have contributed to these two issues.The patient did try to turn the stimulation off and the result was that the burning sensation improved slightly, but then their leg pain came back since the therapy was off, so they turned it back on.The patient hasn't seen their doctor for about a year because they never had an issue with their therapy until this event.They were redirected to see their doctor to address the therapy and symptoms.

Event Description

On (b)(6) 2020, additional information was received from the patient.Patient reported they had their device checked by healthcare provider (hcp) on (b)(6) 2020.After the doctor checked the implanted devices, they were unable to determine the cause of not feeling stimulation in the right leg and burning at the ins site.Possible treatment will include a shot.The manufacturer representative (rep) reprogrammed the device.The issue was not resolved.The patient was keeping it turned off at bedtime because they can't seem to get it where they needed it so they can sleep.No further complications were reported/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.

• 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: 10456702
• MDR Text Key: 204541266
• Report Number: 3004209178-2020-14814
• 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
• Report Date: 09/23/2020

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: 08/28/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 92