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

Model Number 97714

Device Problems Overheating of Device (1437); Use of Device Problem (1670); Delayed Charge Time (2586); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Burning Sensation (2146); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain indications.Caller met with patient today and patient reported issues with communicating to ins with patient programmer (pp).Patient uses the antenna and has to apply pressure to get the pp and ins to communicate.Caller noted the ins is pretty superficial, she could feel the ins.Caller does not know if the pp worked better without the antenna.Caller met with patient and was told patient recharger paddle gets very hot while charging.No known error codes or messages noted on the recharger (insr).Caller will have patient contact patient services with equipment for additional troubleshooting/replacement.Additional information was received from a manufacturer representative (rep).It was reported that the issue reported was related to the patient programmer and ins communication.The patient reported that he has to apply significant pressure over implant site for the pp to communicate with ins.Having to apply this pressure requires getting into compromising positions for shoulders and lb and causes pain.They reported that the ins feels ¿somewhat¿ superficial, but not as superficial as when the device was first implanted.He reported weight fluctuations and recalls that the superficiality is directly related to his weight but does not relate to the communication issues.Pt will be contacting patient services to acquire refurbished pp and recharger to rule out any errors on that end.This information was also confirmed with a physician/account.Additional information was received.It was reported that they had issues with both the recharger and the pt programmer connecting to the implantable neurostimulator (ins).Pt said the recharger did not have coupling bars when charging their ins unless they put a lot of pressure on the recharger antenna against their ins.Pt said they actually put a rolled up towel against the recharger antenna and lay on the towel against their back and still the pt never g ot the "full 10 bars." pt mentioned the recharge time was close to 8 hours and the recharger antenna got hot to the touch.Pt mentioned they got "no bars without pressure" and the right spot for connectivity on their back was just left of the ins.Pt also said they had issues with the connection of the pt programmer.Pt said "it was almost impossible to get connectivity." pt said they had to place the pt programmer antenna against their back and lean into the antenna and press real hard to get the antenna to connect to the ins.Pt said sometimes they had to press the sync button 6-9 times before they could get the ins connected to the antenna.Pt said issues occurred both with and without the pt programmer antenna attached.Issue with pt programmer also started "a long time ago." the pt spoke to a manufacturer representative (rep) and the rep said the pt should call pats and have their equipment replaced before the pt considered doing anything "medical".A replacement programmer antenna, programmer, and recharger antenna were sent out.Rep responded back and reported that they heard back from the patient and confirmed that the connectivity issue of the pt programmer to the ins has been resolved.He said the pt programmer has ¿excellent connectivity¿, but he still needs time to assess the recharger antenna.Rep will follow up with more updates as soon as they hear them.

Manufacturer Narrative

Continuation of d10: product id 97740 lot# serial# (b)(6) implanted: explanted: product type programmer, patient product id 37791 lot# serial# unknown implanted: explanted: product type recharger product id 37092 lot# serial# unknown implanted: explanted: product type multiple therapy product section d information references the main component of the system.Other relevant device(s) are: product id: 37791, serial/lot #: unknown, ubd: , udi#: this regulatory report is being submitted as part of a retrospective review as part of remediation plan 411 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18951081
• MDR Text Key: 338997964
• Report Number: 3004209178-2024-07521
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2022
• Date Device Manufactured: 10/25/2016
• 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 Sex: Male