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 Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Erythema (1840); Headache (1880); Unspecified Infection (1930); Pain (1994); Malaise (2359); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

Event Type  Injury  

Manufacturer Narrative

Device avail.Eval: product id 3777-60, lot# serial# (b)(4).Implanted: (b)(6) 2013 explanted: product type lead information references the main component of the system.Other relevant device(s) are: product id: 3777-60, serial/lot #: (b)(4), ubd: 09-aug-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain and headache.It was reported that 5 days ago they were at the mall and heard a loud pitched sound and felt this was maybe coming from their implant.The patient stated that shortly after that they got a puffy neck, headaches and they just didn't feel good.They stated that there was swelling on the back of their neck where the wire was.The patient stated that their was a red mark and that it hurts.They went to the clinic and had an x-ray, which showed nothing abnormal.The patient stated that they put the patient on antibiotics right after christmas and that had not helped them.

Manufacturer Narrative

Continuation of d10: product id: 3777-60, serial# (b)(6), implanted: (b)(6) 2013, 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.

Event Description

It was reported that patient could not get their battery to charge about 10 months ago out.Pt didn't seem to need it anymore so due to covid-19, they didn't report it.Recently, a month ago, patient had swelling lower back of head and patient did hear a strange sound coming from that area?? took antibiotics and swelling went away.Decided to have it checked and no doctor in their area could help them.So patient called the manufacturer and found out battery is dead.Patient had no other answer for the swelling etc.Patient will go to a different town to have it taken out.For whatever reason, patient do not seem to have the pain anymore and patient has health needs that may require mri so patient believes it is for the best to remove it.Patient believes the swelling was in the area of the wire, however, with the dead battery, patient was confused.Patient had no change in activity.It hurt and itched in that area.Doctors noticed the red mark and the "lumps" swelling.So they gave patient antibiotics.It went away.The issue was resolved.Doctors thought there may be infection - really not sure.Doctors wanted patient to see the doctor who did the last surgery 7 years ago.

Event Description

Additional information was received from a healthcare provider (hcp) via a manufacturer representative (rep) reporting that the patient would have their scs system explanted on (b)(6) 2021.The reason for the explant was unknown, but elective.

Manufacturer Narrative

Continuation of d10: product id 3777-60 serial# (b)(6) implanted: (b)(6) 2013 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: 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: 11269767
• MDR Text Key: 232330927
• Report Number: 3004209178-2021-01847
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 89