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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Numbness (2415); Shaking/Tremors (2515)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2015.Product type: lead product id 977a260, serial# (b)(4).Implanted: (b)(6) 2015.Product type lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 16-jul-2019, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 16-jul-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care professional and a consumer regarding a patient who is implanted with a neurostimulator for spinal pain.It was reported that when the patient first had surgery, on the first attempt in 2015, the implanting physician had nicked a nerve and the first attempt was aborted because the leg was shaking all over.The patient slept overnight, and then did the implant the next day and it was working just fine.The left leg goes numb all the time now.The patient has also fallen three times; however, the dates of the falls are unknown.Information received on apr 13, 2017 indicated that the patient was getting an mri, and it was unknown if it was related to the device or therapy.The patient reported having back pain and weak lower left extremity that is progressively getting worse since implant.Additionally, on dec 02, 2019, it was reported that the patient also has had back pain which is sporadic; however, they have been having back pain for the past three months.There were no further complications reported.

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 on (b)(6) 2020.It was reported that while attempting to do the implant on (b)(6) 2015, a nerve was "bumped".They had to spend the night in the hospital, and the next day the implant procedure was completed.Since (b)(6) 2015, the patient has had pain in their left foot and the left foot was giving out on them, which resulted in them falling 3 times.They were redirected to discuss symptoms with the patient's doctor.No further complications were reported or anticipated.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9519966
• MDR Text Key: 185501308
• Report Number: 3004209178-2019-24411
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR