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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37751, serial#: unknown, product type: recharger.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018 explanted: (b)(6) 2019 product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018 explanted: (b)(6) 2019, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2018 explanted: (b)(6) 2019, product type: lead.Product id: 977a260, serial/lot #: (b)(4), ubd: 20-jul-2022, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 20-jul-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding an implantable neurostimulator (ins).It was reported that the patient goes to charge the ins with their recharger they are seeing the check antenna screen and then the reposition antenna screen.The patient tried to connect with their programmer and were able to do that.The patient took the panel off the recharger and the antenna fell out, so they plugged it back in and was able to start charging the ins.Troubleshooting resolved the issue.No symptoms were reported.No further complications were reported or are anticipated.(b)(6) 2020 additional information was received from the patient.Patient stated they don't think this device helped much, tylenol is better.Patient provided the model number of the recharger and stated the screw came out.(b)(6) 2020 additional information was received from the patient.It was reported that the device was not doing the job - sometimes partly doing the job.Patient repositioned the device, attempted to change the programming.Took it out and did some repositioning and other work.The issue was not resolved.Patient clarified he meant leads that were there before, slipped and were replaced with the paddle lead less than a year ago to see if that will make the device help patient more.It has not.Patient did not know the exact date of the surgery.He added that hcp says they have done everything they can with the device to see if it helps the patient.There are no further options as any further surgeries will be too risky given patient¿s health and age.Manufacturer representative has worked with patient and tried to reprogram.Rep also agrees with the hcp that there is nothing else that can be done.Patient stated that he does not know what else to do either.Patient also clarified that the screw in the recharger fell out.He put it back in a nd everything with the recharger works fine.Patient did not know if the explanted leads were returned.

Manufacturer Narrative

Correction: updated a4, patient weight information.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.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: 10346127
• MDR Text Key: 201558690
• Report Number: 3004209178-2020-13160
• 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
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 72