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); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 07/27/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, lot/serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: 977a260, serial/lot #: (b)(4), ubd: 13-jun-2022, udi#: (b)(4).Non-healthcare professional.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 non-malignant pain.It was reported that the patient's device was implanted for their left leg and lower back.The patient was receiving relief in both their left leg and lower back at first but a few days ago it stopped.If the patient increased stimulation they only felt it in their left leg but not their low back.In the last few days, the patient also had pain at the lead wire implant site.It was painful to lay down on it so they had to lay on their side.The patient was going to have their spouse look at the site later to see if it was red or looked infected.There were no related falls, traumas, or electromagnetic interference.During the call, the consumer connected the controller which showed that stimulation was on and they were on program a at 2.8v.The consumer moved to program b and then moved program b from 0.1v to 4.4v.It was noted that the patient felt it comfortably and would "give it a few hours" to see if these changes helped.No further complications were reported.

Manufacturer Narrative

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

• 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: 7740139
• MDR Text Key: 116261859
• Report Number: 3004209178-2018-17173
• 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: 10/04/2018

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: 06/14/2019
• 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: 07/30/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Date Device Manufactured: 06/21/2018
• 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: 47 YR