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

Model Number NEU_UNKNOWN

Device Problems Energy Output Problem (1431); Charging Problem (2892); Electromagnetic Compatibility Problem (2927)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2021

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 (pt) regarding an implantable neurostimulator (ins).The reason for call was caller stated they had found a job in a bakery with high voltage equipment and noticed their implant was effected by this.Caller stated that they felt "surges" and noticed they would have to charge the implant battery more often.Caller was worried this would cause implant damage so they quit.Caller stated since quitting everything is ok and back to normal charge frequency.

• Brand Name: NEUROMODULATION DEVICE
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 12527378
• MDR Text Key: 273171070
• Report Number: 2182207-2021-01653
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN
• Device Catalogue Number: NEU_UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• 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