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); Therapy Delivered to Incorrect Body Area (1508); Data Problem (3196)

Patient Problems Abdominal Pain (1685); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Date 02/23/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger, product id: 97745, serial#: (b)(4), product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient had been getting rm04 when they charged the ins and they would reset the controller to bypass the message.One day they reset the controller 5 times.They then reported that the area around the ins was hot.When trying to clarify if the hotness was external or internal the patient stated "yes".They reported that they were getting rm04 all the time, the recharger was overheating, and the controller had bent connector pins.The patient felt that their stimulation increased drastically and they had pain in the stomach area.They were advised to reduce stimulation and they should shut stimulation off if they couldn¿t.They mentioned they had a problem with the implant that was a temporary fix.They further reported that their stimulation increased suddenly without the patient making stimulation changes.Once stimulation increased from 10 to 29.95.They felt it through their stomach and they had been hurting because of it.When it happened their stomach blew up like a basketball.The patient stated they wouldn't choose to have their settings so high.No further complications were reported or 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 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: 9836371
• MDR Text Key: 183561734
• Report Number: 3004209178-2020-05466
• 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: 03/16/2020

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: 03/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/16/2020
• Date Device Manufactured: 03/27/2019
• 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 Age: 66 YR