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

Model Number 97714

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Overheating of Device (1437); Communication or Transmission Problem (2896)

Patient Problems Burn(s) (1757); Pain (1994); Burning Sensation (2146)

Event Type  malfunction  

Event Description

Information was received from a patient regarding an implantable neurostimulator.The reason for call was patient stated that the magnet thing on the recharger is burning them.Patient stated that it gets real hot and burnt a hole in their skin.Patient also stated that they can't get their equipment to find the implant.Patient reported that they cannot do anything with their device or equipment; patient followed up saying that they think their implant is moving.Patient stated that they lost some weight; patient went from 3909 to 176 they think.Patient noted that the recharger drains the controller battery and that they always have to recharge the controller.Patient mentioned that they can feel the implant moving and that they are not sure where the implant currently is.Patient also mentioned that they are in a lot of pain; patient requested a mdt rep to assist them because their doctor has nothing to do with their implant.When asked for an event date; patient stated that the issue has been going on for months and months and months.Agent asked for the serial number on the patients recharger; patient gave intellis serial number and agent documented this.Agent reviewed the information with the patient.The issue was not resolved.Agent sent an email to repair to replace the recharger and an email to the field for visibility.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name intellis; product id 97755 (serial:(b)(6)); product type: 0213-recharger medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19152979
• MDR Text Key: 341080265
• Report Number: 3004209178-2024-09492
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: 04/22/2024

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 Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 01/07/2014
• 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
• Treatment: SEE H11...
• Patient Sex: Female