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

Model Number 37713

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 377760, lot# v015321, implanted: (b)(6) 2006, product type lead.Other relevant device(s) are: product id: 377760, serial/lot #: (b)(4), ubd: 21-nov-2010, udi#: (b)(4).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

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient's lead was fractured and not in use.

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.They reported that they needed to know if they could get an mri done even though pt had a "fractured" wires in place.When the pts implantable neurostimulator (ins) was taken out it was done by their healthcare provider (hcp) and when they removed the leads one of the leads fractured and was still there.Pt said a different doctor replaced the ins and said they could not get that lead out.When pt got the removal of the ins one of the leads fractured and the doctor could not get the lead out; they "dicked" around with it.Patient saw the other doctor who put the new ins in.During the lead removal they could not get a hold of the lead for they were afraid they would paralyze the pt.The other hcp said they could not get the lead out.Pt wanted to know if the abandon lead was in them could they get an mri of their back or not, mri guidelines were reviewed.The pt had lots of medical problems and need mris; that was the main reason why they removed the original ins and leads so they cou ld get mris.The patient was redirected to their healthcare provider to further address the issue.2023-dec-23: additional information was received from the patient.They called back repeating when they replaced the implant the hcp fractured the wire.The fractured wire was still in the back.Pt was told they could not have an mri.Pt mentioned they could not find an hcp who could remove the abandoned lead.Pt was concerned about the wire floating around.Pt asked for help finding an hcp.Provided hcp listings over the phone.Pt also wanted to know what the manufacturer thought of their fractured wire, if it was ok, why it was fractured, and whether other pts had this happen.Reviewed manufacturer role, redirected to hcp.Reviewed clinical summary.Reviewed if the wire gets removed, hcp can send it for analysis.Reviewed electrocautery guidelines.

• Brand Name: RESTORE ADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14990885
• MDR Text Key: 304613667
• Report Number: 3004209178-2022-08834
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2007
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 12/23/2023
• Supplement Dates FDA Received: 01/18/2024
• Date Device Manufactured: 10/14/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female