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

Model Number 97715

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927); Impedance Problem (2950); Insufficient Information (3190)

Patient Problems Memory Loss/Impairment (1958); Pain (1994); Therapeutic Effects, Unexpected (2099); Dizziness (2194); Complaint, Ill-Defined (2331); Cognitive Changes (2551); Electric Shock (2554)

Event Date 08/27/2019

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 and manufacturing representative (rep) regarding the patient's implantable neurostimulator (ins).Information was reported that the patient stated that she fell on the ice "sometime ago," but cannot recall when or where she fell.The patient also noted that she landed on her back.The patient also stated that she's had a problem ever since her ins was implanted in her upper back, nothing that she was advised to call patient services to have somebody set up an appointment with a manufacturer representative (rep) to look at her leads.The patient said she doesn't know if there's a problem with the leads in her back, nothing that she's having a memory issue as well.The patient reported that she is getting shocking sensations, interactions from having two systems in, and a memory impatient that she related to the ins.The patient did note that when she fell she may have hit her head.She is uncertain and feels it's the implant that is impacting her memory.It was noted that is sounds like her md is unwilling to remove the ins as he does not feel it has anything to do with her complaints.The patient was also advised to turn off their stimulation.The patient then stated that since her new ins was implanted, she feels like it's messed with her head.The patient then mentioned that since she fell on the ice in (b)(6) or (b)(6) she has had memory issues.The patient then added that about three months ago, she noticed that when she goes to charge her older ins, her intellis implant "thumps" in her back.The patient was asked to clarify the meaning of the thump and she said "it send out a shock." the patient noted again that she saw her managing healthcare provider (hcp) who said it might be the leads.The patient noted again that she is having a hard time with them both.The patient noted that her old ins worked fine until the new one was implanted.The patient also mentioned that due to her devices her hcp have her down for mental retardation and memory issues.This is because of the dizziness and memory loss.The patient is afraid to use her devices/therapy because the more she "uses them the worse it gets." the patient reiterated multiple times that she has short term memory issues.The patient also stated her controller broke and turned fuzzy.The patient explained that the controller screen went blank and after she plugged it in overnight, it came back on.The patient called back and stated she accidently sent back the wrong patient programmer (pp), noting that the person she was visiting in (b)(6) sent back the new pp and she still has her original pp.The patient was unclear as to what the issue was with the pp, but alleged that something was wrong with the way the icons appeared in the top row of the pp when the ins is fully charged.The patient has called back multiple times, but does not have her equipment to troubleshoot with to determined what the issue is.It was also noted that the patient was unclear, and sometimes muffled and incoherent while on the multiple phone calls.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

Additional review indicated that patient code applies.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative regarding the patient.It was reported that the patient is claiming that the device is causing memory loss and not controlling her pain.Additionally, it was reported that the patient alleges that the remotes are acting up.The patient was reprogrammed on (b)(6) 2020.The patient was reprogrammed with one electrode that was out of range during an impedance check.There were no further complications 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: 9786573
• MDR Text Key: 182136741
• Report Number: 3004209178-2020-04603
• 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,Followup,Followup
• Report Date: 03/29/2020

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: 03/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 03/04/2020; 03/05/2020
• Supplement Dates FDA Received: 03/04/2020; 03/29/2020
• Date Device Manufactured: 03/25/2019
• 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: 45 YR