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

Model Number 97714

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97714, serial#: (b)(4), implanted: (b)(6) 2015, product type: implantable neurostim ulator.Refer to regulatory report # (b)(4).The patient had two implanted systems and it was not clear which issues pertained to which implanted system.The referenced report pertains to the patient¿s other system.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the reason for call was the patient said they were having an issue with their stimulation.The patient further explained that it felt like there was a "hiccup" in their stimulation.The patient said they could lay on their back to make the stimulation feel stronger, however, they feel the stimulation shut off and come back on quick.The patient said it started about 2-3 months about but was becoming more frequent.The patient said they rely on their stimulation heavily due to their back being "pretty jacked up".The patient was redirected to their healthcare provider to further address the issue.

Manufacturer Narrative

Continuation of d10: product id 97714 lot# serial# (b)(6).Implanted: (b)(6) 2015.Explanted: product type implantable neurostim ulator.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

The patient met with a manufacturer representative on (b)(6) 2021.It was noted that the change in stimulation is irregular for the patient, and there does not seem to be a pattern.The sensation of the stimulation cutting off shortly is not a shocking or tingling feeling.Impedance values are all normal, and adaptivestim is not enabled for this patient.The patient is going to continue monitoring the changes.

• Brand Name: SURESCAN
• 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
• MDR Report Key: 12341828
• MDR Text Key: 267249831
• Report Number: 3004209178-2021-12636
• 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
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 49 YR