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

Model Number 37712

Device Problems Break (1069); Degraded (1153); Difficult to Remove (1528); Connection Problem (2900)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3998, lot#: v001559, implanted: (b)(6) 2006,explanted: (b)(6) 2020, product type: lead.Product id: 3998, serial/lot #: (b)(4), ubd: 07-dec-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received via a manufacturer representative from a health care professional regarding a patient who is implanted with a neurostimulator.It was reported that the patient presented for a battery replacement.The surgeon had a difficult time removing the lead from the port of the old implantable neurostimulator, and then could not get it to go into the new battery.Additional contributing factors were unknown.The surgeon attempted to insert the lead into the new implantable neurostimulator port multiple times and tried the bottom port; however, the issue did not resolve.The surgeon ended up replacing the entire system to resolve the issue.There were no further complications reported or anticipated.

Event Description

Additional information was received from the patient on (b)(6) 2022.Pt mentioned that from her most recent implant in 2020 they replaced the leads due to normal corrosion after 20 years and hcp wanted to start fresh.

Manufacturer Narrative

Continuation of d10: product id 3998, lot#/serial (b)(6), implanted: (b)(6) 2006, explanted: (b)(6) 2020, 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 ULTRA
• 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: 10309436
• MDR Text Key: 199978731
• Report Number: 3004209178-2020-12635
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Date Device Manufactured: 01/14/2011
• 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 Age: 49 YR
• Patient Sex: Female