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

Model Number 97715

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Tingling (2171); Complaint, Ill-Defined (2331); Irritability (2421); Abdominal Cramps (2543); Ambulation Difficulties (2544)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative (rep) via a consumer regarding a patient who was implanted with a neurostimulator.It was reported that patient was feeling paresthesia and tingling in their legs even when the ins has not been turned on.No troubleshooting was done as of yet.Rep stated that the patient was implanted the night before and was groggy as a results of the anesthesia so they did not turn the ins on.The patient came in for an appointment the day of the report to have the device programmed and reported the sensation in legs.Rep wanted to know if it could be symptoms of spinal pressure, or pressure on the spinal cord or if healthcare professional irritated the nerve.Evaluation and imaging was recommended.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 on (b)(6) 2018 from an account via a manufacturer representative reporting that it was verified the device was off by using the patient programmer.It was unknown what the cause was.Patient stated that paresthesia had gone away while the device was off.There were no actions taken.Additional information was received form the consumer on (b)(6) 2018 reporting that the leg tingling went away 2 days later.The patent was programmed by a manufacturer representative on (b)(6) 2018 because the patient had difficulty moving their extremities (both legs).The patient had been agitated, had weakness in legs, and abdominal cramps.The ins was shut off at the time.Since march 8th the patient had been in contact with another representative and at some point therapy was turned back on.The patient was in a wheelchair and unable to stand.Their right leg was being addressed by physical therapy and was better.The left leg strength had not come back which caused the patient to not be able to walk or stand.The patient was going to see the health care provider (hcp) and manufacturer representative on (b)(6) 2018.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 manufacture representative (rep) reporting that another rep was at an appointment with the patient today (2018-03-21) and referred to continue follow-up with the other rep.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 manufacture representative (rep) reporting the patient's device was set to a mild level of stimulation with a lower amplitude and pulse width to resolve the patient's leg weakness and difficulty standing/walking.It as indicated that the cause was not determined.It was indicated that the provided information had been confirmed with the physician.No further complications were reported/anticipated.

• 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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7310258
• MDR Text Key: 101567955
• Report Number: 3007566237-2018-00626
• Device Sequence Number: 1
• Product Code: LGW
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2018

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: 01/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 03/05/2018; 03/21/2018; 04/30/2018
• Supplement Dates FDA Received: 03/21/2018; 04/09/2018; 05/07/2018
• Date Device Manufactured: 02/02/2018
• 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 Age: 46 YR