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); Overheating of Device (1437); Human-Device Interface Problem (2949)

Patient Problems Aspiration/Inhalation (1725); Cardiopulmonary Arrest (1765); Pain (1994); Swelling (2091); Burning Sensation (2146); Complaint, Ill-Defined (2331); Coma (2417)

Event Date 11/02/2018

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 a neurostimulator for spinal pain.It was reported that the battery site had a burning sensation from the inside out.When stimulation was on or the ins was recharging the patient had a severe burning pain.It was reported that the consumer probably dismissed any of the symptoms until almost a week to a week and a half ago.It was hard to sit down and lean against somethings.3-4 days ago it got to the patient that the patient could not sleep on it, it was swollen, and was extremely hard.The consumer was concerned because there was some haste with installation trouble.When in surgery the patient aspirated into lungs and coded.They had to be transferred and was in a coma for 5 days.There were in the middle of the procedure when this happened so the patient was concerned and questioned if everything got installed properly.The stimulation had been turned on (b)(6) 2018.The surgical site on their back formed a large bump which subsided when stimulation was turned off.It started out mild and was now about the size of a jawbreaker.Last night ((b)(6) 2018) they turned stimulation off for 6-7 hours and it went down significantly.The morning of the report the consumer charged and they were back to the burning sensation.The consumer had been playing around with the settings and had it on the lower side for the last couple of days.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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8135114
• MDR Text Key: 129434837
• Report Number: 3004209178-2018-26966
• 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
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• Date Device Manufactured: 10/02/2018
• 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 Outcome(s): Life Threatening
• Patient Age: 43 YR