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

Model Number 97712

Device Problems Failure to Deliver Energy (1211); Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial#: (b)(4), product type: lead. Product id: 977a260, serial#: (b)(4), product type: lead. Product id: 977a260, serial/lot #: (b)(4), ubd: , udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: , udi#: (b)(4). Date of event is year valid. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that their stimulation was not working, it would give them one shock and then quit when they try to turn stim on with their patient programmer (would show the lightening bolt indicating stim was on). The patient said they do not use an antenna with their patient programmer. The patient said when they turn their stimulation on using their recharger, it will turn on, but the stimulation would be "going too fast" and they can't turn it down so they just turn it off. The patient said their programmer batteries showed full charge and the ins was about half charged. An email was sent to the repair department to replace the device. It was reviewed that if the replacement patient programmer does not resolve their problem, they should follow up with their healthcare provider (hcp) for further troubleshooting and to check the ins. The patient called back and was able to use the patient programmer to connect to the implant and the patient programmer showed settings 8. 5v and therapy is on but the patient was not feeling stimulation. It was asked if the patient had a fall or trauma and the patient stated he tripped over a post 4 days ago. Patient stated he thinks something happened with his lead because when he is sitting, there is no stimulation but when he gets up and moves a little then he can feel stimulation. It was reviewed that getting another patient programmer will not change the information on the patient programmer screen or the stimulation. Patient asked about a manufacturer representative (rep) and the rep's role was reviewed and recommend that the patient consult with his healthcare provider for next steps.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 11961192
• MDR Text Key: 255440043
• Report Number: 3004209178-2021-09019
• Device Sequence Number: 1
• Product Code: LGW
• 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,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial