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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Burning Sensation (2146); Tingling (2171); Electric Shock (2554)

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 manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for radicular pain syndrome (radiculopathies) and spinal pain.The rep reported that the patient was experiencing intense tingling and burning.The rep was not with the patient at the time of the call for troubleshooting.The rep reported that the patient had used the therapy about 5% in the past year.Stimulation was currently off, confirmed by the clinician programmer.The rep was not aware of any historical impedances.There was no known activity or event that prompted the issue.The rep reported that the ins was on the contralateral side as the symptoms.The rep was not aware of any weight changes or pocket issues.The rep reported that they would present the information to the healthcare provider (hcp).It was noted to be a sudden change in symptoms.The rep reported that this had started in the last week or so, but had happened in the past as well and gone away on its own.Additional information was received from a rep on (b)(6) 2018.The rep reported that the cause of the intense tingling and burning was not determined.The rep reported that the intense tingling and burning had not been resolved but the patient was pursuing an appointment with the hcp to remove the system.The rep reported that telemetry was performed on the ins to ensure it was turned off, which it was.Additional information was received from the patient on 2018-01-09.The patient reported that she¿s been having some difficulties she believed were related to her ins.The patient reported that ¿when it is turned off she can still feel stimulation and it has gotten to the point where the stimulation she is feeling is to the level of shocking her.¿ the patient reported that she had been to the emergency room (er) several times and has been told ¿the device can't do that since it¿s turned off.¿ the patient reported that she saw a rep who verified that it was turned off and she was sent for an mri for this and was now asking to have the device removed.The patient reported that for a number of months she¿s been able to feel stimulation with the implant off.The patient reported that it was different than residual stimulation.The patient reported that it wasn't bothering her at first because it was at a low level.The patient reported that about 6 months ago she saw a rep to check it and they confirmed the ins had turned off.The patient reported that this last week on 2 separate occasions its ¿ramped up to where it is unbearable¿ and she went to the er after this starting on (b)(6) 2018.No further complications were reported.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7178809
• MDR Text Key: 97731801
• Report Number: 3004209178-2018-00540
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2018

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 Expiration Date: 06/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 01/10/2018
• Date Device Manufactured: 07/30/2015
• 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