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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the patient¿s wife regarding the patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient was unable to recharge.There were no known external factors that may have led to the issue.No troubleshooting had been performed yet, but the rep had preliminary plans to meet with the patient on (b)(6) at the doctor¿s office.The issue had not yet been resolved.It was indicated that the patient¿s wife called them on (b)(6) 2018 to tell them about their husband being unable to charge their device.It was indicated that they had not had stimulation for two weeks.No surgical action occurred and it was asked but was unknown if there was any planned, but the rep indicated they would follow-up for more information.It was reported the event occurred on (b)(6) 2018.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a health care provider (hcp) via a manufacturer representative on (b)(6) 2018 reporting that the patient saw their hcp on (b)(6) 2018."a por was successfully accomplished." the patient was receiving good therapy and the lead was negative for impedance issues.It was confirmed that the device had been overdischarged and was now fully charged at the end of the appointment.No further complications were reported.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient via the manufacturer representative (rep) on march 3, 2020.It was reported th at the ins had gone into overdischarge again and the patient wasn't sure if it was the 2nd or 3rd overdischarge.The rep met with the patient to interrogate the ins and the recharger displayed end of service (eos).The rep informed the patient that the overdischarge was the 3rd strike.The patient's clinic would be setting up an ins replacement surgery.No further complications were reported or anticipated.

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 the rep.It was reported that surgery was cancelled on (b)(6) due to covid-19.Surgery to be rescheduled however date has not been determined.The device will be returned dependent upon facility regulations.

• 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: 7570194
• MDR Text Key: 110118644
• Report Number: 3004209178-2018-12624
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR