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

Model Number 97714

Device Problems Break (1069); Failure to Deliver Energy (1211); High impedance (1291); Delayed Charge Time (2586); Patient Device Interaction Problem (4001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2021, product type: lead.Product id: 3778-60, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 3778-60, serial/lot #: (b)(4), ubd: 02-feb-2020, udi#: (b)(4); product id: 3778-60, serial/lot #: (b)(4), ubd: 02-feb-2020, udi#: (b)(4).Device evaluated by mfr: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.H6 codes belong to the leads.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer via the manufacturer representative regarding a patient with an implantable neurostimulator (ins) for occipital nerve stimulation.It was reported that the patient presented with slow charging issues which escalated to loss of stimulation on one side.It was discovered that there was high impedance on the right lead.The patient has had no falls but a contributing factor was the patient turns her head a lot.Troubleshooting was performed on (b)(6) 2021.Tested impedance at each connecting point (battery, extensions and leads) to determine the location of the issue.Only one lead was fractured, it was unknown which lead it was.It was noted that the patient was only booked for investigation of the cause of the high impedance.The surgeon wanted to determine the site of the high impedance (leads or extension) to determine if lead replacement would be needed.The patient preferred not to have to shave her head and get the leads replaced if it wasn¿t a lead issue, therefore the operating room was only booked on (b)(6) 2021 for the purpose of checking if it was a lead or extension issue.Both leads were replaced on (b)(6) 2021 and the impedance checks were okay.The ins remained implanted as it had no issues.The issue was resolved at the time of this report.The patient w as alive with no injury.

Manufacturer Narrative

H6.Device analysis for lead (b)(6) revealed the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the #6 conductor was broken at electrode #6 crimp sleeve, 4.6 cm from the distal end of the lead; consistent with explant damage.The epoxy were broken under electrodes #0, #1, #2, #3, #4, #5, #6, and #7 in electrode area at the distal end of the lead; consistent with overstress damage.The report said that there was only one lead with high impedance and only one lead was fractured, it was unknown which lead it was.Therefore, concluded that this lead was functioning and was performing at the time before explanted.With the fact that it was functioning before it was retrieved from the patient, and broken conductor was identified after it was returned.It was suspected that the explant process played a role of the broken conductor.Device analysis for lead (b)(6) revealed conductors #0 #1 #2 #3 #4 and #5 were broken at electrode area at multiple locations in electrode area.Epoxy were broken under all electrodes in electrode area.Outer insulation had multiple breached cuts and melted insulation.H6 codes belong to the leads.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
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11724187
• MDR Text Key: 247265881
• Report Number: 3004209178-2021-06650
• Device Sequence Number: 1
• Product Code: LGW
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

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: 11/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention