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

Model Number 97715

Device Problem Environmental Compatibility Problem (2929)

Patient Problem Electric Shock (2554)

Event Date 03/01/2020

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 healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the ins was statically charged.The patient who had high dose (hd) stimulation complained that sparks burst from them when they touched metal surfaces.An example given was when the patient was getting in the car.The ins was now off for most of the day.The patient felt that the static feeling was gone when the ins was switched off.The issue was considered unresolved as of (b)(6)2020.It was noted that the doctor wanted to know if this phenomenon was known to the manufacturer.No surgical intervention occurred or was planned.The patient was alive with no injury.The issue occurred during normal use.Additional information received reported that no cause could be determined.The physician would continue to monitor the patient.

• Brand Name: INTELLIS
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9977669
• MDR Text Key: 199990753
• Report Number: 2182207-2020-00148
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2020
• 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