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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2013, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 17-sep-2017, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 17-sep-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins).Information was reported that the patient stated that she was told in 2015 or 2016 that her leads had fallen to the bottom of her spine and she has been taking time to get the ins redone.The patient stated that she lost her insurance and moved, but has an x-ray today where she was told that her leads were visible.The patient noted she is not certain on where exactly her leads are.The patient also stated that they used the wrong leads, and that they should have used a paddle leads.The patient stated that she was seeing new pain and the doctor wanted to replace the system due to the wrong leads being implanted.The patient's device is currently inoperable and has been for years.The patient clarified that the doctor wanted to replace the system in 2016/2017.The call was dropped before any additional information was given.No further complications were reported.No patient symptoms were reported.

• 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: 9722962
• MDR Text Key: 184331610
• Report Number: 3004209178-2020-03591
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Date Device Manufactured: 09/18/2013
• 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