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 To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330); Electric Shock (2554)

Event Date 03/08/2018

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 with an implantable neurostimulator (ins) for non-malignant pain.The patient stated that t hey cannot turn their stimulation off.It is supposed to be in hd but if they roll over in the bed they feel a shocking and can feel as much ld as they do hd.It also happens when they are sitting up too.The patient did not have the stimulation on until a week after the implant and when they turned it on is right when the shocking sensation started.The patient told their manufacture representative (rep) about this about 2 weeks after the implant was put in.The rep checked them in different positions and they did different readings and changed the settings.Patient services offered to help the patient turn the stimulation off but they did not have their equipment with them so they would call back.The symptoms reported included uncomfortable stimulation.The patient called back on (b)(6) 2018 with their equipment.Patient services offered to assist the patient in turning the stimulation off but the patient stated that they know how to turn the stimulation off.However, once it is off they can still feel the stimulation.The stimulation has been off for a few days/couple days, then stated that the stimulation has been off for a week.Patient services reviewed residual stimulation considerations but the patient said that they don't think they should still feel it after a week.The controller states that the stimulation is off.The patient called their doctor to let them know.They saw 2 people who came down to the hcp¿s office and one of them tweaked the stimulation.The patient stated that it first started a couple days ago then stated a week.The patient was redirected to follow up with their healthcare professional (hcp).No further complications were reported/are 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: 7422417
• MDR Text Key: 105388272
• Report Number: 3004209178-2018-07817
• 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
• Report Date: 04/11/2018

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: 01/28/2019
• 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: 03/15/2018
• Initial Date FDA Received: 04/11/2018
• Date Device Manufactured: 02/07/2018
• 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: 56 YR