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

Model Number 97715

Device Problems Low impedance (2285); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for occipital neuralgia and spinal pain.It was reported that the patient was seeing "settings not available" for probably about the last month or so.They had no recent falls or traumas.When the patient decreases stim she sees the message less frequently, but needs higher stim to help with pain settings.They emailed the health care professional but they redirected to patient services thinking it was a controller issue.They confirmed screen meaning and irrelevance to controller or li battery level.The patient was redirected to their healthcare provider to further address the issue.Additional information received from the manufacturing representative (rep) indicated that reports patient(pt) getting desired settings not available (oor) on the controller.Impedance check showed electrode 8 <(>&<)>11 at 20 ohms, however those electrodes/lead is not being programmed.Impedance for all other electrodes are 600-800 ohms.Rep said the highest program parameter is for prog#1 at 0- 2- 4+ 390usec, 115hz, at 6.1ma.Other 3 programs have similar parameters, but he ma are less than 2.8ma, and simple bipole for some of the programs.Patient services discussed lowering the pulse width to allow more ma to be delivered, however, pt needs that higher pulse width to get coverage.The rep was to further reprogram the patient.Additional information was received from the manufacturing representative (rep).The rep responded to the questions, patient's weight was unknown.The rep was able to get a program for the patient that worked, oor resolved.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11350072
• MDR Text Key: 243691170
• Report Number: 3004209178-2021-02907
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Date Device Manufactured: 07/22/2020
• 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: 38 YR