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

Model Number 97714

Device Problems Battery Problem (2885); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 07/01/2020

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 manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that there were discharges.The device discharged six times a day.Factors that may have led or contributed to the issue was no event.Troubleshooting included checking impedances which were okay, changing programs, stopping the adaptive stimulation, and stopping stimulation where there were no more discharge.An appointment was scheduled with the doctor on (b)(6) 2020.The issue was not resolved.The patient stopped the ins and would use an external neurostimulator until the scheduled appointment.The patient was alive with injury.Additional information was received reporting that the lead was tested in the operating room, the patient can¿t use the internal stimulation anymore.The patient uses external stimulation.No action or change was planned.

• Brand Name: SURESCAN
• 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: 10804523
• MDR Text Key: 216664787
• Report Number: 2182207-2020-01234
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/06/2020

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 Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/06/2020
• 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): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 90