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

Model Number 97714

Device Problems Intermittent Continuity (1121); High impedance (1291); Unintended Collision (1429); Low impedance (2285); Delayed Charge Time (2586); Patient Device Interaction Problem (4001)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the patient via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was also reported that the patient felt like therapy was turning on and off on its own.While testing with the therapy on, the patient stated that the therapy turned off and then on even though the rep confirmed that the therapy was on the whole time on their clinician programmer.The patient did not have adaptive stimulation or cycling enabled.Technical services advised to have the patient keep a log to see if they experience this in different positions, to see if it is positionally related.It was unknown when this began.It was noted however, that the patient had a fall in (b)(6) 2020.It was also reported that the patient indicated that charging was taking longer than it used to, which was also unknown when this began.The rep performed an impedance check with the patient and stated that there were multiple possible shorts and opens.It was reported that with reference 0: contacts 0 through 3 were below 50 ohms, but it was noted that the patient does not use any of these contacts in their programming.Reference 5: contacts 11 and 12 were over 10,000 ohms.The rep stated that the impedances were fluctuating between 6,000 to 9 ,600 ohms.After further clarification, the rep stated that this was when they would cycle between different reference electrodes.The patient was only using contact 5 and 7 on program a, which were all between 800 to 900 ohms.They rep instructed the patient to only use this program for the time being.The impedance issues were discovered on (b)(6) 2020.

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 was received from a manufacturer¿s representative (rep).The rep reported that they met with the patient on 2020 (b)(6) and they checked impedances in several different positions and even while transitioning between positions.Contacts 11 and 12 remained to be over 10,00 ohms and contact 3 remained to be less than 50 ohms.The cause of the impedance issues wasn¿t clear.The rep programmed around those leads.The rep reported that while the patient was walking around or reclining in her sleep number bed was when she noticed it feeling like it was turning on and off.The patient did admit that instead of it turning off it actually just felt really weak instead of being completely off.The managing physician ordered x-rays to confirm lead placement.The x-rays showed that the lead had not moved.The managing physician was going to try additional therapies with the patient.The rep reeducated the patient on positional changes and the patient agreed that some of the strong versus very weak sensational changes could be related to position.It was unclear what the recharging issues were.The patient forgot to bring their recharging equipment to the appointment.The rep asked the patient to follow up with them for questions or help troubleshooting recharging equipment.The patient didn¿t seem concerned with her recharging time at the appointment on 2020-(b)(6).The rep encouraged the patient to reach out regarding the recharging issue.

• 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: 10309525
• MDR Text Key: 199935581
• Report Number: 3004209178-2020-12636
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 91