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

Model Number 97715

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Burning Sensation (2146); Cramp(s) (2193)

Event Date 05/24/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97715, lot#:, serial#: (b)(4), implanted: (b)(6) 2018, explanted:, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient and a health care professional reported that patient was told by his health care professional that he should have his device reset.The patient needs his implantable neurostimulator reprogrammed as he got tased several times over memorial day weekend and the patient suffered some trauma.The patient stated that everything tensed up and they were cramping up when the tasing happening.Now the implantable neurostimulator is not working right and it is actually causing more pain.A manufacturer representative reported that the patient has both thoracic and cervical systems, and both had been working great until the patient was tased 5 times.Since then, the systems have not been working right, so the patient turned them off.All impedances were checked on both systems, and they were all green and under 1000 ohms.When they turned either implantable neurostimulator on, no matter where programming was on the leads, when the amplitude was turned up, the patient would feel an intense burning and a painful muscle cramping/spasm sensation behind their right clavicle.With both systems at low amplitudes, the patient still felt the tingling/stimulation in the right areas, but as soon as they would start to feel it and the amplitude was increased, they would feel the painful sensation.Whatever programming that they did on either system, they couldn't obtain coverage without the sensation occurring.

Event Description

The rep reported that they ran an impedance test.The rep reported that there were no reports of emi, just the taser.The rep reported that the patient had a change in stimulation after being tasered.Impedances were within normal limits, programs were tested out and still feeling tingling sensation right and left sides for both cervical and thoracic systems, but also felt severe cramping muscle spasming and burning in right clavicle when both systems were on separately.The spasming stopped when stimulation was turned off.The patient would be leaving both systems off at time.Nothing further was being done at this time.

Manufacturer Narrative

Continuation of d11: product id 97715, serial# (b)(6), implanted: (b)(6) 2018, product type: implantable neurostimulator.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: INTELLIS
• 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 00777
• MDR Report Key: 10562916
• MDR Text Key: 207904556
• Report Number: 3004209178-2020-16364
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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
• Report Date: 09/30/2020

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: 06/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR