MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 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 Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Pain (1994); Ambulation Difficulties (2544)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 03-mar-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had permanent nerve damage.The patient said from the moment they woke up in recovery it was clear something was wrong.The patient had severe pain and hypersensitivity in both of their legs.It was a 10/10 on the pain scale.The patient was sent to the icu.They spent the night on ketamine to try and get the pain under control, but the pain was so bad that the breeze of someone walking by would cause them pain.The patient was transferred to a different floor and they stayed in the hospital for 3 more days.It was difficult for the patient to walk and they used a walker.During the adjustment to fix it, the patient developed pain in their left side where the leads traveled down to the battery.After months of adjusting settings, the hcp removed the device.The patient said they still have pain and hypersensitivity in their les and feet even though the device is removed and it has been 3 years since implant.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10757345
• MDR Text Key: 213861054
• Report Number: 3004209178-2020-18949
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Date Device Manufactured: 05/11/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 34 YR