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

Model Number 97715

Device Problems Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Human-Device Interface Problem (2949); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 10/10/2019

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 consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that since implant, the ins had never worked.It was meant to manage the patient's lower back pain and lower extremity pain.It was explained that the trial was really effective but since getting the permanent implant, they were not getting therapeutic effect.Following implant, they started experiencing an "electrical jolting" down their leg with positional movement, and it has worsened since implant.Additionally, the patient reported the stimulation felt like a "tingle all the time and it was unmerciful".It was noted that the metal hip the patient had from a total hip replacement on the left side, may be contributing to the tingling sensation they were always feeling.The patient had met with a rep for reprogramming to try and resolve these issues.They also tried all of the groups but could not turn down the stimulation enough to no longer feel the stimulation sensation.Then, in the beginning of (b)(6) 2020, the patient had an acute onset of hip pain in their right hip (same side as the implant).This "really bad pain" was the cause of the patient becoming "non-ambulatory" and was "having a terrible time".It was noted that prior to the acute onset of pain, the patient had been doing some lifting and bending and had also fallen on some ice.They inquired if these incidents could have caused damage to the internal components.The patient did have an x-ray of their hip, which didn't identify any fractures and was "not surgical".The patient had been getting hip injections.The patient also turned off the ins for about 5-6 weeks, but did want it to be interrogated.A request was made to meet with a rep in the area as the patient was visiting family out of state for the winter.A request was sent out to the field to inform them of the patient's request.A rep responded stating they would contact the patient.The patient was also redirected to see their doctor to check their devices.No further complications were reported or anticipated.

Manufacturer Narrative

Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2019, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported that the patient's temp eval went very well (patient likely referring to trial stimulator).However the patient's doctor advised the patient he had real difficulty installing the permanent wires in (b)(6) 2019.By november the effectiveness has dropped off by 60%.The patient noted that they went south for the winter, and found themselves in excruciating pain in their right hip and knee.The patient was seeing a pain specialist.It was suspected the new wires had contacted a nerve.The pain became so bad that the unit was turned off.The patient went from totally physically functional to handicapped and having to use a walker in two months.The patient was told it would only help herniated disks in their spine.Now the patient was being told to run a trial on each program since it will help their hip and knee.The patient went from totally active with back pain to using a walker religiously because of the hip and knee pain, the patient's back pain disappeared.The install of the patient's permanent ins has been a total disaster for the patient's mobility.The patient noted being 100% disabled from combat.No further information was 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 before leaving for out of town the (b)(6) of 2020, the patient had recognized 60% less efficacy and extreme pain had appeared in the right hip and knee.Upon arrival in (b)(6), the patient sought medical help from three pain doctors.Two of which injected pain medication into her hip and then knee with little to no relief.A neurologist x-rayed the patient¿s hip for possible surgery.The hip, while compromised, was not a prospect for surgery.The health care professional surmised that the implantable neurostimulator wires were adversely affecting a nerve and that the unit should be turned off.The patient was in extreme pain in the right hip and knee shortly after the installation of the device.This remains unresolved.The patient has another appointment with her health care professional on (b)(6) 2020 to remove the unit.There was conflicting information received about the patient's weight noting it as (b)(6) pounds instead of the (b)(6) previously reported.There were no further complications reported.

Event Description

Additional information received from the consumer reported that no actions were taken to resolve the wires contacting a nerve and the pain.The patient had opted to have the device removed (b)(6).

Manufacturer Narrative

Continuation of d11: product id 977a260 lot# serial# (b)(6) implanted: (b)(6)explanted: product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) explanted: 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.

• 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: 9792610
• MDR Text Key: 182149892
• Report Number: 3004209178-2020-04680
• 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: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 139