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 Problem (1431); Device Difficult to Program or Calibrate (1496); Therapy Delivered to Incorrect Body Area (1508); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Neuropathy (1983); Device Overstimulation of Tissue (1991); Pain (1994)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a160, serial#: (b)(4), product type: lead; product id: 977a260, serial#: (b)(4), product type: lead.Other relevant device(s) are: product id: 977a160, serial/lot#: (b)(4), ubd: 18-dec-2018, udi#: (b)(4); product id: 977a260, serial/lot#: (b)(4), ubd: 16-jan-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that since the implant the pulsing kept going in her hands.Patient stated this had always been a problem with programming to get the stimulation away from the hands.Patient stated last year having an x-ray and the leads had shifted.Patient stated turning off ins until she could meet with someone for programming but because of covid they have not been able to.Patient mentioned injections on top of the head for cluster nerves.No further complications were reported/anticipated.

Event Description

Additional information was received from the patient reporting that back in (b)(6), they had an x-ray done, which showed their leads had changed.The patient indicated that they were a very athletic person, so the leads had slipped down and ever since, they constantly were having trouble with their stimulator.They stated that they felt like it was buzzing/frying their hands a lot and they turned it way down.The patient indicated that ever since it went into their body, ¿they had to relocate it as they were too thin and they put it up in their shoulder¿.They stated that ¿it was clicking on everything¿.They stated that it would ¿go away and everywhere they sat they relocated it to their lower body¿.Ever since day 1, every program and problem they had, they had buzzing in their hands.They stated that this had been going on for a long time.Once the leads changed/migrated, this issue was magnified.Again, it was noted that an x-ray done on (b)(6) 2019, confirmed that the leads had migrated in the past few years (noted: think they were implanted in 2017).The patient indicated that they told their pain management doctor about this, however, they didn't want to monkey with it, with everything else that was going on with the patient.The patient was advised to keep their settings low and in the background, while dealing with their other medical issues.The patient then stated that while they were keeping it low and turned on in the background, they were doing other things and the patient turned it off.They stated that they tried to charge it and keep it on low.They stated that at one point they turned it off and went to charge it and was very weak as they were very sick and they didn¿t want to sit on the charger because it was really painful, so they turned it off.They indicated that this occurred throughout the year until march and they didn¿t deal with it as they were dealing with a bunch of other stuff.The patient indicated that they felt like their hands were fine and that they were still dealing with this on an ongoing basis.They stated that they were trying to reprogram their unit, but they thought because their pain problem was not so much a ¿usage pain, but an ongoing nerve damage pain¿, that they were just trying to find the right program that hit the right point on the nerve.They noted that it was not so much, ¿that they had a moved nerve and it hurts¿, it is a "just exist and it hurts type of pain".Therefore, they stated that this made programming kind of hard.No further complications were reported/anticipated.

Manufacturer Narrative

Continuation of d11: product id 977a160, serial# (b)(6), product type lead, product id 977a260, serial# (b)(6), product type lead.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: 10160842
• MDR Text Key: 199302102
• Report Number: 3004209178-2020-10411
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 39 YR