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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Electric Shock (2554)

Event Date 10/06/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received regarding a patient with an implantable neurostimulator (ins), and it was reported that the patient would have a burning sensation in her back.The patient stated this would be on each side of the lead, and would go up her neck and the middle of her back.Each side of the top of the leads around the patient's shoulder blade would burn and was painful.The patient could not bend and felt shocking.The patient stated the device beeps.The patient reported pain and couldn't bend, as that would affect the patient more.The patient was not getting stim through program 3, but it was determined program 3 was off, the patient was able to turn program 3 on, but reported that program 4 worked best.The patient was redirected to their hcp.There were no reported complications and no further complications were expected.Patient was implanted for non-malignant pain and complex regional pain syndrome type 1.

Manufacturer Narrative

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

Event Description

Additional information received from the consumer reported that they met with a manufacturer representative on (b)(6).The representative found there were two yellow dots and was able to fix which vertebrae were targeted with the computer.The patient stated the representative couldn¿t fix the burning, shocking, pain or stiffness.The patient was trying to seeing a healthcare professional for their symptoms.

• 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: 9539977
• MDR Text Key: 176581185
• Report Number: 3004209178-2020-00064
• 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
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• 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
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2018
• 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: 72 YR
• Patient Weight: 50