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

Model Number 97714

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Fall (1848); Ischemia (1942); Pain (1994); Renal Failure (2041); Concussion (2192); Brain Injury (2219); Electric Shock (2554); Insufficient Information (4580)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

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 patient said their ins hadn't worked since date of implant and they couldn't charge their ins and they have not used the system in a long time.The patient said if they get near a tv or radio the wire interacts with the signal.The patient said they were woken up during their implant surgery and they got off of the table and started to kick their health care provider (hcp).The patient moved from wi to co last year and they started to feel shocks and jolts from their ins due to the underground cables.Invisible fences cause the patient to feel shocks.One of the shocks that the patient received caused them to fall off their stool, another caused them tohit their head and it cracked open.The patient said they smashed their head 3 times and they received concussions and has a traumatic brain injury and said it is all due to their ins.The patient said their ins destroyed their spine.The patient wants people to know that ins' do not help a person and they hold medtronic responsible.The patient blames part of their problems on not being woken up during their (b)(6) 2016 surgery.Due to the medical issues that resulted from having a ins they are unable to take medications any longer, the patient specifically mentioned gabapentin.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the manufacturer representative (rep).The rep was contacted to confirm the information provided by the patient and the rep reported they have no information to provide regarding this event.

Event Description

The patient reported previously documented events.New information received indicated the patient's wires outside were being affected by a 5g tower and zaps everywhere.The pt also noted that "after 2 years of surgery of what the ins did, it crushed their skull" and damaged their kidneys.The pt then stated, "i have a high red blood count from this machine and being abused.My red blood was affecting my kidneys, they are shutting down.I had been bleeding from them for ten months." the pt also reported painful electrocution of their kidneys.Pt also reported that "their oxygen was being cut off [to] their blood supply to their head.".

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: 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: 12269530
• MDR Text Key: 264819393
• Report Number: 3004209178-2021-11846
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

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: 06/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 08/12/2022
• Date Device Manufactured: 08/12/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female