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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Nausea (1970); Dizziness (2194); Ambulation Difficulties (2544)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 09-jan-2023, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(4), ubd: 12-dec-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient called the rep on (b)(6) 2019, to meet for a normal reprogramming.When the patient met with the patient on (b)(6) 2019, the patient said he had cupping done by his physical therapist on (b)(6) 2019, and since that appointment, the patient has had intermittent nausea and dizziness/balance issues.The patient said he's tried turning the stimulator on and off and seems to find a correlation between the symptoms and when the ins on.The patient never had any issues before the cupping appointment.The patient said they specifically told the physical therapist to not go down his spine with the technique, but they did nonetheless.Impedances were normal and connectivity tests showed no issues.An x-ray was done and noticed that one of the two leads had migrated, but it was of an insubstantial amount.No other visible damage on the x-ray or any other indicators that the scs system was comprised of.The rep tried a different program and asked the patient to run it at a lower amount than he had previously to see if those symptoms return as he was running it quite a bit higher than previously.The rep was going to re-evaluate with the patient a week following the report.The patient was told if the symptoms come on, to turn the device off and contact the rep again.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: 8793879
• MDR Text Key: 151186538
• Report Number: 3004209178-2019-13596
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2019

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: 01/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/16/2019
• Date Device Manufactured: 02/12/2019
• 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: 53 YR