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 Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Malaise (2359)

Event Date 07/06/2012

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3778-60, serial# (b)(4), product type: lead; product id: 3778-60, serial# (b)(4); product type: lead.Other relevant device(s) are: product id: 3778-60, serial/lot #: (b)(4), ubd: 26-mar-2016, udi#: (b)(4); product id: 3778-60, serial/lot #: (b)(4), ubd: 17-nov-2015, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - complex reg pain syndrome type i/ spinal pain.It was reported that after implant the rep came to program patient's device however once she started increasing patient felt in her right leg instead of her left leg and also mentioned that the rep kept increasing the setting to the point that it hurt so the patient told the rep to stop because they were not feeling well.Patient stated that they had a few follow-up appointments in which it was finally determined that the surgeon implanted the leads in the wrong position; they were reversed.Patient stated that it was finally programmed so that it was providing coverage.No further complications were reported/anticipated.

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.

• 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: 8842815
• MDR Text Key: 152694056
• Report Number: 3004209178-2019-14603
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR