MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SPECIFY SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 977C165

Device Problems High impedance (1291); Insufficient Information (3190)

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 a healthcare provider (hcp) via manufacturer representative.It was reported that the lower half of the electrode was not working, so it was swapped out with a different one that the manufacturer representative brought.It was further reported that when the hcp stimulated the caudal region of the electrode, they were not getting the results they typically expected.The physiological responses were unusual or nonexistent.When the mid-level electrodes were activated, it also produced irregular responses on the opposite limb.Impedances were checked throughout the procedure and high impedances were reported, although they were less than 10,000 ohms.It was noted that the impedances progressively grew higher throughout the procedure and different contacts increased/decreased.The hcp stated that based on those results, they had reason to suspect that there was an issue with the electrode.It was noted that the issue was resolved when the electrode was replaced, as the physiological responses were higher and more accurate.However, the manufacturer representative noted that the impedance of the new electrode was similar to the initial reading.It was noted that the manufacturer representative may have kept or disposed of the electrode.No further complications were reported or anticipated.Indication for use is unknown.

Event Description

Additional information received from a manufacturer representative (rep).It was reported that there were no impedance issues when the lead was tested and zero connectivity problems.There was nothing to make the rep assume there were issues with the lead.It was noted that there was a significant change in the location of the new paddle placement.

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: SPECIFY SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8705752
• MDR Text Key: 148308311
• Report Number: 3007566237-2019-01317
• Device Sequence Number: 1
• Product Code: GZB
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2022
• Device Model Number: 977C165
• Device Catalogue Number: 977C165
• Device Lot Number: VA1VMSS026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1