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

Model Number 97702

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Environmental Compatibility Problem (2929)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 03/13/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial# (b)(4), product type: programmer, patient; 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.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2015, the patient reported a loss of therapy.Stimulation was not helping his pain like it used to.The change in therapy/symptoms was considered gradual.This occurred in (b)(6) 2015.The patient's relevant medical history includes non-malignant pain and chronic low back pain.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, the event will be updated.On (b)(6) 2018, additional information was received from the patient¿s friend/family member reporting that they had been having back pain.The caller was asking if the manufacturer representative (rep) could meet with the patient at the hospital (patient is in hospital for reasons unrelated to their device/therapy).The patient stated they were off all pain pills and was not using their stimulator because it did not help them.They stated when they first got their stimulator it was working and then about a month after that, the patient was scrubbing the carpet and since then the stimulator had not worked the same.The patient had an appointment to meet with their physician assistant and rep in a couple of weeks.It was reported that the patient needed an mri of the head, not related to the their implant.During the call, the caller stated they saw the eri on the programmer.Patient services helped them clear the eri.It was stated the programmer showed the ins was off, they stated they knew this because it was not working for the patient.It was reported that the pain in the back began about a month after implant (2015).No further complications were reported/anticipated.

• 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: 7575548
• MDR Text Key: 110704172
• Report Number: 3004209178-2018-12793
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2018
• Date Device Manufactured: 11/24/2014
• 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: 80 YR