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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Malaise (2359); Weight Changes (2607)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.The patient reported that she had the stimulation adjusted last tuesday and was told to wait a week to give the adjustments time to work.The patient reported that she still had an upset stomach, so she was considering having the device removed.Additional information was received from a healthcare provider (hcp).The hcp reported that the device wasn¿t relieving pain.Additional information was received from the patient on (b)(6) 2020.The patient reported that she wanted to let a manufacturer¿s representative (rep) that she turned the ins off because she couldn¿t eat and now, she was able to eat.The patient didn¿t want to turn the ins back on because she was grateful that she was able to eat.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

On 2019-jul-12, information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for lumbar radiculopathy and spinal pain.It was reported that the patient needed someone to come out to their house to turn up their stimulation, because when they turn up the stimulation they have an upset stomach and pain on their left leg, buttock and foot.There were no traumas or falls that may have led to the issue.It was recommended that the patient consult with their hcp.The event occurred a week ago in (b)(6) 2019.No further complications were reported/anticipated.On 2019-jul-25, additional information was received from the patient reporting that on (b)(6) 2019 the issue of the patient having an upset stomach and pain in their left leg, buttock and foot when their stimulation was turned up had been resolved.The patient¿s weight at the time of the event was requested, but was not addressed.No further complications were reported/anticipated.On 2020-jan-15, additional information was received from the patient reporting that the patient was trying to get the implant out because their therapy was not helping them and was causing them more back pain.They stated that they couldn¿t turn stimulation up because stimulation made them sick and lose weight, so they had stimulation at a very low setting.The patient stated that they were seeing their surgeon soon to remove the device.The patient reported that their therapy hadn¿t helped them for two to three years.No further complications were reported/anticipated.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 9654312
• MDR Text Key: 185414523
• Report Number: 3004209178-2020-02312
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Date Device Manufactured: 12/20/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR