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

Model Number 97712

Device Problems Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Energy Output To Patient Tissue Incorrect (1209); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Device Operates Differently Than Expected (2913); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Twitching (2172); Therapeutic Response, Decreased (2271); Discomfort (2330); Electric Shock (2554)

Event Date 04/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018; crts (b)(4) (con): information was received from a consumer regarding a patient implanted with an implantable neurostimulator (ins) for non-malignant pain and post lumbar laminectomy syndrome.It was reported that the patient (pt) insides felt like a light switch being flicked on and off; the stimulation was like it was jerking.It was confirmed that this occurred even when the implant was off.It was further stated that the pt had to lower her stimulations levels.The pt had 3 programs and could feel them differently than normal.It was stated that this was sudden and strong.The pt sated that in her normal position, she would be in at the same level but the stimulation would be very strong.It was mentioned that this occurred when the implant was on and she had to lower her levels.It was mentioned that due to the issue, it was helping some with the pain but not like it should because she could not turn her levels up.The pt was redirected to their health care professional (hcp) to address the issues and a hcp listing was sent via email.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.The patient reported intermittent rib pain.The patient reported that she had some fall but thought the issues started prior to the fall which are all around the same time frame.The patient reported that she wasn¿t able to keep the stimulation level where she needed it to control the pain at time because stimulation was too strong.The patient reported that she could be standing and taking a breath and she would get a jolting in the rib intermittently.The patient reported that the stimulation was traveling and it jolted as it moved.The patient reported that she felt stimulation in areas that she was not supposed to feel stimulation, such as high in the back or the whole front torso from the breast to the waist and in different parts of the leg.The patient reported that sometimes the right side, leg up would feel like a jolt.The patient also reported that she used to be able to charge the ins about every 2 weeks and now she was charging every week or sometimes twice a week.The patient reported that she was making more adjustments and could sometimes have stimulation higher.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer regarding the patient.It was reported that the stimulation will move places.If she decreases the settings, the patient can barely feel it and her back hurts more.If stimulation is increased, the patient can feel it in the ribs, but she does not have the pain in the front.She noted that this is not positional and not due to changing positions.If she takes a deep breath, she can feel the stimulation move and it is painful.The stimulation will all of a sudden get strong in the back or legs without changing positions.There was no trauma or fall noted to have contributed to the issue.The patient noted that this suddenly started occurring a few months prior to the report, confirmed as 2018.The patient noted that the lead was not replaced in (b)(6) of 2017, and that just the implantable neurostimulator was replaced due to normal longevity.There were no further complications reported.

Event Description

Additional information received from the consumer reported that the device wasn¿t working properly and they didn¿t know what was wrong.The patient mentioned having rib pain and charging frequently and that it had gotten worse since last time.

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.

Manufacturer Narrative

Continuation of d10: product id 3888-33.Lot# v340247.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 the patient.The caller noted that for over 3 years they've had issues with their leads.Caller stated the leads have been in for over 10 years and it doesn't always register even when it's fully charged.Caller stated that sometimes the stimulation will come up into their chest like it misfires.Caller stated it's uncomfortable but the improvement in the pain in their low back is worth the occasional discomfort.

• 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
• 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: 7563185
• MDR Text Key: 109913299
• Report Number: 3004209178-2018-12433
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 09/17/2018; 06/10/2019; 02/26/2020; 01/20/2023
• Supplement Dates FDA Received: 09/20/2018; 06/14/2019; 03/10/2020; 01/23/2023
• Date Device Manufactured: 04/03/2017
• 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...."
• Patient Age: 43 YR
• Patient Sex: Female