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); Unstable (1667); Data Problem (3196)

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

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) for non-malignant pain.It was reported that the patient called and stated today that they were noticing when they were using their device it would change intensities without them using their device/equipment.They denied that they had adaptive stimulation on and had stated that they had turned off the device for the last four weeks due to the discomfort.The patient stated that they did not need to change positions for the intensities to change.The rep verified that the patient did not have adaptive stimulation enabled and the rep indicated that they spoke at great length with the patient regarding adaptive stimulation and remote use.The patient stated that they turned the stimulator off and back on to have the device be set at different intensities each time.The issue was not resolved at the time of the report.No surgical intervention occurred or was planned.The event date was asked and was unknown and would not be made available.No further complications were reported/anticipated.

Event Description

Additional information was received from the patient (b)(6) 2019, that the stimulation was changing on its own all by itself.The patient just turned it off for the past couple of months.The patient has been working with some manufacturer representatives (rep) also, the patient reported that the healthcare professional (hcp) mentioned the device flipped, however, the patient thinks it doesn't make sense and it has not been confirmed.A replacement programmer was sent to the patient due to the complaint that the programmer was changing on its own.There were no further complications or anticipations reported with this event.

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: 9360269
• MDR Text Key: 176236908
• Report Number: 3004209178-2019-22372
• 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: 01/12/2020

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: 12/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1