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

Model Number 97714

Device Problems Display or Visual Feedback Problem (1184); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Neurological Deficit/Dysfunction (1982); Neuropathy (1983); Pain (1994); Sleep Dysfunction (2517); Electric Shock (2554)

Event Date 08/26/2019

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 consumer regarding a patient who is implanted with a neurostimulator for spinal pain.It was reported that when the patient goes into a recline or lying down position, the pain in her arms and legs make her stay straight out and stiffen up.Someone has to help the patient put her feet on the floor and then her whole body will relax.Stimulation is verified to be on when this happen, and the patient has adaptive stim enabled.The patient declined to increase and/or decrease the amplitude, and would like to meet with her health care professional and manufacturer representative.The patient indicated that this issue had been occurring for the past three months, confirmed as starting in 2019.The patient had thought that her patient programmer batteries were getting low, and she did not know why.It was clarified that the patient was seeing that the icon that indicates that the implantable neurostimulator battery was getting low.Additional information was received from the patient.It was reported that there were no changes to programming since the device was implanted.As a result, the patient said they had a stiffening of their body, severe neuropathy, and dystonia.The patient said the zapping charges from the device like there was a loose connection.The patient said no diagnostics were done with the patient in the reclined position.A tech showed the patient how to increase/decrease amplitude.The patient said they were still having issues daily.Since seeing a rep, the patient was a lot better, but they were still having night time/sleeping issues.The patient said the cause was not determined and offered conflicting info stating that they have never seen the hcp or rep since implant.The patient then provided conflicting information again stating that a rep was awesome and helped the zapping issues and programmed stim relief from the patient's waist to their toes, something they hadn't felt for 5 years.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: 9681210
• MDR Text Key: 178204278
• Report Number: 3004209178-2020-02796
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/07/2020

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 Expiration Date: 10/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/07/2020
• Date Device Manufactured: 12/06/2014
• 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: 61 YR
• Patient Weight: 61