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

Model Number 97715

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Muscle Weakness (1967); Muscular Rigidity (1968); Nausea (1970); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Tingling (2171); Myalgia (2238); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 12/14/2017

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 consumer regarding a patient who was implanted with a neurostimulator for malignant pain.It was reported that the patient has been sick for over a week and he had to quit using the device because it was making him more nauseous.He turns off the device at night.As soon as he turned the device on, on (b)(6) 2018, he vomited.The patient turned it off and he had been using it sparingly until (b)(6) 2018.The patient was also using it sparingly until it can be adjusted because he is feeling a lot of stimulation in his groin which has been making him nauseous for a while.The patient was implanted for pain in his feet and lower legs, but the stimulation is mostly tingly in his upper legs and thighs which has been occurring since implant.It is making him clench a lot, making his muscles sore, and his legs have gotten weak.He had it adjusted a couple of times.It is now helping his lower legs a little more, but he still has no help in his feet.He also says that he has an incontinence problem that he takes medication to control, but the implantable neurostimulator has been causing him a lot of accidents with his bladder starting in (b)(6) of 2018.Additionally, the patient notes that if he moves in the wrong direction or if he doesn¿t lay right, it gives him a jolt, or it hurts.The patient also mentioned that he can feel the implantable neurostimulator sticking out of his back and it feels kind of like a ball implanted in his back.This had been occurring since implant.The patient was redirected to his health care provider to discuss his symptoms and settings.The patient confirmed an appointment with his health care provider for (b)(6) 2018.There were no further complications 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 the steps that were taken (or will be taken) to try to resolve the jolting feeling while being in certain positions was to see a manufacturer representative.The jolting feeling while being in certain positions has not resolved.There were no further complications reported.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7363382
• MDR Text Key: 103309870
• Report Number: 3004209178-2018-05582
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

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: 11/14/2018
• 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: 03/15/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 04/17/2018
• Date Device Manufactured: 11/18/2017
• 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: 48 YR