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

Model Number 97712

Device Problems Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Loss of consciousness (2418); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Other: loss of consciousness.Other relevant device(s) are: product id: 09100-60, serial/lot #: unknown; product id: 37082-40, serial/lot #: unknown.Foreign: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via a manufacturer representative regarding the patient who was implanted with a neurostimulator.It was reported that the patient had an off-label procedure and the implant was not registered.The product/therapy was arranged by the patient through an overseas proctor.The patient felt an electric current through the body, then lost consciousness.The implanting surgeon thought it might be electrodes touching each other causing the shock sensation.It was noted that an mri was done at 1.5 tesla.The lead was not tested for mri safe, the implanted extension was not mri safe, and the implanted battery might have not been on mri mode when the mri was done but this was still unknown.Impedance was checked by the agent at the healthcare professional rooms and after the impedance check, the patient lost consciousness.No intervention was done besides the impedance check.The patient would go to theatre on (b)(6) 2018 to get teflon patches implanted provided by the patient's mother.The issue was not resolved as of (b)(6) 2018.According to the surgeon report, allodynia, vascular changes, and burning on the side of the face were noted as patient medical history.The patient was alive with the injury of feeling electric waves/shocks then losing consciousness.The issue occurred during normal use.

Manufacturer Narrative

Upon further review, the serial number of the ins was known and section d fields were updated accordingly.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep.It was unknown when the patient first started experiencing the shocking and losses of consciousness.The serial number of the ins was provided, but the serial numbers of the lead and extension were unknown.The patient's weight was unknown.It was also unknown if the shocking and losses of consciousness were resolved.A report received from the surgeon's practice was provided.It was noted that the patient's mri was done once a year.A telemetry printout and electrode impedance results were provided with electrode 0 used as the reference, and all values were with within normal range ranging from 1264 ohms to 1578 ohms.The medical record for the mri noted the indication as follow-up imaging due to a previous history of trigeminal neuralgia treated with surgery and radiation, with post-treatment radiation necrosis.A comparison was made to the prior phase of imaging which occurred in (b)(6) 2017.Eleven scans were done.In the cerebrum there was evidence of previous left parietal craniectomy.A significant artifact from temporomandibular joint hardware was visible.Previously evident increased signal intensity in the left medial temporal lobe remained visible on "flair" imaging but improved serially.There was mild ex vacuo dilatation of the temporal horn of the left lateral ventricle.There was some macrocystic lohse.Postcontrast enhancement inferomedially to the temporal horn of the left lateral ventricle was unchanged when compared to the imaging from september of 2017.Regarding the cerebrospinal fluid (csf) spaces of the supratentorial region, the lateral and third ventricles were normal in size and configuration with no extra-axial abnormalities.In the pituitary region, the optic nerves, chiasm, pituitary stalk, and pituitary gland were normal.The cerebellum was normal with no focal lesions or pathological enhancement.There was no tonsillar herniation.Regarding the brainstem, the craniocervical junction, medulla, pons, and mesencephalon were normal.The csf spaces of the infratentorial region showed a normal fourth ventricle and basal cisterns, and there were no extra-axial lesions.The visualized orbital structures were normal.The sinuses were clear.There was right turbinate hypertophy with a deviated nasal septum concave to the right.The inner and middle ear structures as demonstrated were normal.The impression noted that features were consistent with radiation necrosis.Additional information was received from the rep.It was noted that the site where the lead was implanted was in south africa.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• MDR Report Key: 7769371
• MDR Text Key: 116642244
• Report Number: 3007566237-2018-02371
• Device Sequence Number: 1
• Product Code: LGW
• 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: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• 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: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention