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

Model Number 97712

Device Problems Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Sleep Dysfunction (2517)

Event Date 06/22/2021

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 who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that  last night the patient started having issues feeling their stimulation to their ribs which had never happened before and it kept the patient up all night.Patient had to turn their stimulation intensity down lower than normal and when the patient went to turn their intensity down they got a signal then the stimulator shut off.Caller said they could turn their stimulator on but every time they turned their stimulator on, their stimulator turned off.The patient said that when they hit the more or less intensity they got a message that said 'press neurostimulator message'.Patient was annoyed with this issue and said their stimulator was short circuited.Patient informed their manufacturer representative (rep)  about the issue today for they felt the stimulation in their stomach and ribs and the rep redirected patient to call patient services (pss) for the time being for the rep was busy.During the call, the patient pressed the on and off button which cleared the message.Pss advised caller to clear the information screen by pressing the up or down navigator key, then to turn the neurostimulator on and try communication again.The patient then decrease intensity and it showed the intensity was at 1.55 then was turned down to 1.50.Patient said they had turned the stim down then off for the stim was shooting into ribs.Patient told pss that the message that they were receiving at the beginning of the call was resolved.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12066415
• MDR Text Key: 258751858
• Report Number: 3004209178-2021-09958
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2021
• Date Device Manufactured: 09/28/2016
• 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 Age: 41 YR