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

Model Number 97712

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Paresthesia (4421)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The patient reported that she has been suffering a lot of pain since (b)(6) 2021.The patient noted that she was sitting in church at the end of (b)(6) 2021, and all of a sudden she had this horrible pain in her right rib, and since then she has had this terrible pain.The patient has had x-rays and 3 injections and is going to physical therapy.The patient "does not know if it is the lead touching a nerve or muscle or what".The patient says that their implantable neurostimulator is supposed to help their pain from where she is fused from l2 to s1, and the sciatica pain on her leg.Additionally, the patient noted that starting in (b)(6) 2021, she feels stimulation and tingly even when it's off.The patient turned the stimulation off on (b)(6) 2021 and somehow the stimulation stays on.The patient noted that it vibrates approximately 5 times a day until she turns it back on again, but it does that even when its off.The patient is certain that she is using her patient programmer correctly and turning stimulation off properly and has not been around any emi.A contributing factor to these issues was noted to be that the patient always falls, and noted that it is possible that she fell around the time that she started feeling stimulation even when it is off.The patient reported that they had told the nurse at their physician office about these issues, and they have an appointment just to talk to the physician on (b)(6) 2021.The patient noted that normally he just gives her the injection and leaves.It was noted that a manufacturer representative would be present at that appointment for reprogramming.

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.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

Caller states patient is reporting tingling at pocket site even with therapy off.Impedance and connectivity tests were performed before caller reached tech services and nothing out of the ordinary appeared.Troubleshooting was not required.The issue was not resolved through troubleshooting.

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 from the rep indicated that they did a connectivity and impedance check, and reprogrammed the patient.The ca use of the patient feeling stimulation when it was off was not determined.The patient indicated they feel the stimulation in their ribs when the intensity is turned up, so they don't turn the intensity up.The event was not resolved.

• 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: 12277944
• MDR Text Key: 265158773
• Report Number: 3004209178-2021-11932
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR