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

Model Number 97715

Device Problems Intermittent Continuity (1121); Unintended Collision (1429)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 03/04/2021

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 (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reports following a fall, pt was feeling like device(stim) is running/surging, feeling suicidal pain that has been going on over a week.Clarified "about 1 week" and pt hasn't slept all night.Pt has turned ins down to 0.0, pt has tried group a and b and finds pain is worse with stim on.Pt has been working with healthcare provider (hcp) and yesterday an xray was done and showed ins and leads are all in place.Pt has an appt tomorrow where a manufacturing representative (rep) will be present.During the call pt was on group a at 0.0 with stm on.Reviewed how to turn stim off.Pt is still in pain with stim off and confirms pain is worse with stim on.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.

• 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: 11476859
• MDR Text Key: 239725243
• Report Number: 3004209178-2021-04242
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2021
• Date Device Manufactured: 06/02/2020
• 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 Outcome(s): Life Threatening
• Patient Age: 67 YR