MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Failure to Deliver Energy (1211); No Device Output (1435); Failure to Power Up (1476); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 37751, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain and lumbar radiculopathy.It was reported the patient's equipment stopped saturday evening.The recharger would not power on, and the patient thought "its all dead now".The patient states they might have seen eos but there were not sure.Patient services reviewed the longevity of their ins and the eri/eos codes, and directed the patient to have their implant checked for a possible over discharge.The patient was getting poor communication on their remote.A replacement recharger was sent to the patient.The patient also reported that for the last couple months their pain has gotten horrendous.All of a sudden their stimulation stopped and wouldn't restart on saturday night.Patient services reviewed a reset.The patient was directed to their healthcare provider to check the implant.No further complications were reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 37751, serial# (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.They stated they received the replacement recharger and it was ¿working wonderful¿.No further patient complications were reported as a result of this event.

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 patient.It was reported that the stimulation just stopped and would not restart so they just kept trying to restart it.The patient said the stimulation stopping and not restarting was not resolved and they were just sent a new recharger.The patient said the pain resolved when they recharged with the new recharger.The patient noted an overdischarge was not confirmed and the problem was the recharger.No further complications were reported/anticipated.

Event Description

Additional information received from the patient reported that they were sent a replacement recharger and that resolved the issue about the pain and the stimulation stopping.

Manufacturer Narrative

Continuation of d11: product id: 37751, serial# (b)(6), product type: recharger.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: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10051650
• MDR Text Key: 190822609
• Report Number: 3004209178-2020-08511
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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,Followup,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2012
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 68 YR
• Patient Weight: 68