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

Model Number 97714

Device Problems Break (1069); Failure to Deliver Energy (1211); High impedance (1291)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id :977a260, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient was not able to feel any paresthesia from the stimulator despite being at her normal intensities levels.Patient does not recall any events that would have led to this.The manufacturer representative met with the patient on (b)(6) 2020.They first tried to control her stimulator with her patient remote.The stimulator was fully charged and on, and they tried all 4 programs she had and went to 10v without any paresthesia.Using the tablet, rep measured the impedances and saw each electrode was over 10,000 ohms at 0.7v impedance check and over 40,000 ohms on 3v impedance check.Rep used each electrode as the reference and it was always over the allowable limits.Rep tried reprogramming and did not get any stim coverage.The managing physician has ordered a thoracic and lumbar x-ray to check for lead migration.Patient has a follow up appointment on (b)(6) 2020 to examine x-ray and decide if she will be referred to a lead revision.The issue was not resolved at the time.

Event Description

Additional information received from the manufacturer representative reported that the patient was scheduled for a lead revision on (b)(6) to replace the fractured lead.

Manufacturer Narrative

Continuation of d11: product id 977a260, serial# (b)(6), implanted: (b)(6) 2016, explanted: product type lead product id 977a260, serial# (b)(6), implanted: (b)(6) 2016, explanted: 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: 10349677
• MDR Text Key: 201171932
• Report Number: 3004209178-2020-13205
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR