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); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Fall (1848); Headache (1880); Pain (1994); Therapeutic Effects, Unexpected (2099); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Ambulation Difficulties (2544); Electric Shock (2554)

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 patient regarding their implantable neurostimulator (ins).Information was reported that the patient fell about 12' and the patient landed on their ins.The fall caused a right 11th rib fracture.The er doctor said from what he sees on the ct scan the device and leads appear to be in the right position, but the device does not seem to be working the same.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

Product id 97745, serial# unknown.Product type programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient clarifying the report of their device was not working the same following their fall.The patient stated that they were having worse shocking/jolting/static electricity, the device was not providing pain relief and they were experiencing more pain from the device after the fall.It was reported that the fall was due to the device jolting/shocking them/not working well as the device caused balance problems.They stated that they were unsteady at walking, and it shocked them when using the bathroom and in the shower causing them to get headaches.It was indicated that the issue was not resolved.The patient also indicated that the battery did not last, was very slow at charging and their remote freezes up.The patient weighed around (b)(6) at the time of the event.The patient wanted to find a surgeon to remove their implant.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

It was mentioned the device was causing anxiety, depression, and social problems.Additional information was received from the patient.It was reported that the controller was still freezing and the patient had to remove the battery to reset it.The patient did not know what caused the issue.The cause of the battery not lasting and charging slowly was not known as it has not been checked.The device was still shocking and jolting static electric and the patient no longer had pain relief.There was pain around the implant and the device got hot while charging.It also caused imbalance problems.No further actions have been taken.No further complications were 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 9707667
• MDR Text Key: 179311816
• Report Number: 3004209178-2020-03287
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Date Device Manufactured: 05/24/2019
• 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 Outcome(s): Other
• Patient Weight: 69