MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_INS_STIMULATOR

Device Problems Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer via the health care provider regarding a patient with an implantable neurostimulator (ins).It was reported that the patient discussed with their doctor and he too felt and found the pocket too wide.The physician pointed out the risks of another surgery, smaller pocket.The patient has considered that.The patient experienced too much pain when sitting against something, a hard back chair, or passenger seat in the car.It went well for a while after the settings were changed, but the patient still has to search gently with their hand.When the patient gets get up in the morning the ins was at an angle, but if they have to get out at night to go to the toilet, it was also at an angle and goes straight again when they stand up.The charger/remote was on sound, but it doesn't give a sound when at 100%, so the patient has to check regularly how far along they are.The pat ient charges at the same time every day, usually 50%, or sometimes 40%.There are days that it charges super fast about 20-30 minutes, but also happens regularly again that it can't find a device.The last few weeks the patient often stops at 90% and leave it like that, lying on the ins just hurts.Yesterday the patient received a message they have never had before, was lying down for about 15 minutes, while he indicated: charging excellent.On (b)(6) 2021 a conclusion was made that there was no dysfunction of the ins or charger but rather mistrust in the system.The patient has had other notifications.A picture showed that the ins was almost completely empty, screen 50, and could not start charging right away but that the current first drips into it.It was noted that the patient had been charging for 15 minutes with a charging quality of excellent.The patient has a consultation on (b)(6) 2021 to discuss revision of the pocket but would like to be sure there was nothing technically wrong with the ins.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11703687
• MDR Text Key: 247349896
• Report Number: 2182207-2021-00672
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• 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): Required Intervention