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

Model Number 37713

Device Problems Break (1069); Difficult to Remove (1528); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2010, product type: lead.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 13-may-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was reported that was received from a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins).Information was reported that they were doing a routine replacement of 97715 for 37713 but both leads are stuck in the 37713 header block even though they have fully backed out the set screws.No obvious corrosion present.Technical services (tss) reviewed trying lubrication in header block area.Caller went to get another torque wrench during call but these didn't resolve the issue.It was later reported that they were unsuccessful in getting it out completely and it fractured off inside of the 37713.They then tried connecting the good lead and it wouldn¿t go in the new ins.The doctor described the connections as feeling tacky and believes glue may have been used on the leads to secure in the old battery.

Manufacturer Narrative

Continuation of d10: product id: 39565-65, lot#serial#: (b)(6), implanted: on (b)(6) 2010, explanted: on (b)(6) 2021, 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.

Event Description

Additional information was received from a patient reporting that they had a lead revision on (b)(6) 2021.The healthcare provider (hcp) found that the leads were "glued into the generator so they had to cut them and replace the paddle and move it up 2 vertebra".The patient mentioned they were still healing from the surgery.

Manufacturer Narrative

Imf code f1205 added to this event.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 ADVANCED
• 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: 11013021
• MDR Text Key: 225377176
• Report Number: 3004209178-2020-21926
• Device Sequence Number: 1
• Product Code: LGW
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2010
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR