MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 37714

Device Problems Break (1069); Migration or Expulsion of Device (1395); Malposition of Device (2616); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Injury (2348); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient.It was reported that the patient received a defective implantable neurostimulator (ins).The consumer stated that the device failed and caused the patient irreparable harm.No further complications were reported or anticipated.Indication for use is non-malignant pain.

Manufacturer Narrative

Continuation of d11: product id 39565-65 serial# (b)(6) implanted: (b)(6) 2015 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

Additional information was received from a legal document.It was reported that the product was manufactured in a defective and unr easonably dangerous condition in that its leads subsequently failed, resulting in injury and damage to the patient.It [the ins] had a characteristic that allowed it to fail and its leads to fail.As a result, the patient was left without the relief that the product was designed to give.The patient underwent pain and suffering and there was a permanent component to their injury.

Event Description

Additional information was received.It was reported in 2015 that the top edge of the stimulator protruded during normal work day hours and caused discomfort as well as concern regarding thinning of the skin over the patient's surgical incision.The top part of the stimulator appeared superficial at level of incision.The stimulator was moved.The patient noted minimal efficacy.The patient noted they had the battery go dead twice as they had been increasing the charge with dwindling efficacy.The healthcare provider took patient to fluoroscopy suite.The spinal cord stimulator was visualized spinal cord stimulator leads and they appeared intact.It was noted at the generator side, it looked like the superior of the 2 contacts had become disconnected from the spinal cord generator.The lead was free in the ins pocket.The inferior lead appeared to be in place.The healthcare provider believed it would be best to replace the ins.It was noted with the lead absent from the female receptacle at the top of the ins, serous fluid may have gotten into the contact pocket rendering it unsuitable for use.The patient noted they had the generator revised recently but half of the lead did not work as there was a disruption in the lead circuit.It was noted the paddle lead had 1 fractured lead, hence the patient was only using one-half of the lead.The patient noted they had some pain and discomfort in their low back area.

Manufacturer Narrative

Continuation of d10: product id 39565-65 lot# serial# (b)(6), implanted: (b)(6) 2015, explanted: 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
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 8081724
• MDR Text Key: 127538578
• Report Number: 3004209178-2018-25654
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2021
• Date Device Manufactured: 10/24/2014
• 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
• Treatment: "SEE H10...."; "SEE H10...."
• Patient Outcome(s): Disability; Required Intervention
• Patient Sex: Male