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

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 97715, serial# (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 06-mar-2019, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 06-mar-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that on group a they should feel stimulation in both legs.They stated they were trying to turn stimulation down on the right leg and turn stimulation up in the left leg, but they were only feeling stimulation in the right leg since (b)(6) 2018 (about a week ago).The patient tried group b and they were feeling stimulation a little bit in the left leg.The patient reported that their ¿leads were messed up¿ for about a year, since 2017.They stated in order for them to feel any type of relief with stimulation they had to ¿lay back¿.Their doctor told them they could do an x-ray to check their lead position, but the patient did not want to do that at the time.It was reported that while the patient was healing from their most recent implant they were in the process of moving and maybe did a little more than they should have.The patient was recommended to follow-up with their healthcare provider ( hcp) to discuss their symptoms and programming.It was indicated that when the patient used their programmer to communicate with their ins it showed that stimulation was on.No falls/traumas/emi activity were related to the event.An email was sent to a manufacturer representative (rep) to reach out to the doctor regarding the patient¿s issue.No further complications were reported/anticipated.See regulatory report #: 3004209178-2018-14574 regarding issue with the "lead being messed up" with previous ins system.

• 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: 7646517
• MDR Text Key: 112857842
• Report Number: 3004209178-2018-14581
• 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: Other
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2015
• 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
• Patient Age: 34 YR