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

Model Number 97713

Device Problems Delayed Charge Time (2586); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Erythema (1840); Irritation (1941); Skin Inflammation/ Irritation (4545)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

On 2019-sep-17, information was received from a healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient¿s device had been dead for about a year and they needed to know their mri compatibility.It was reviewed they were only compatible for head-only mris for a depleted device.The patient was redirected to follow-up with the healthcare provider (hcp).It was asked but was unknown when the event occurred (noted ¿about a year ago¿).No further complications were reported/anticipated.On 2019-oct-04, additional information was received from the patient reporting that the cause of the implant being depleted for a year was because ¿for the longest time the patient¿s unit would not hold a charge¿.The patient was not sure when they last successfully recharged their ins.Actions taken to resolve the depleted ins was the patient has to keep the charger on for long periods of time, causing irritation and redness over the battery.It was indicated that the issue of the ins being depleted was not resolved as the patient was not sure who to turn to for surgery to replace the battery.It was reported that the patient weighed (b)(6) pounds at the time of the event.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient¿s wife reporting that the patient hadn't charged their ins for over a year and the patient gets ¿poor communication¿ when trying to charge the ins.Patient services asked the caller when the patient first received the poor communication screen and the caller was unsure.It was reported that the patient needed an mri and patient services explained that the patient needed to charge their ins and put the ins into mri mode before their mri appointment.Patient services also directed the caller to have the patient follow-up with their healthcare provider (hcp)to address their possible overdischarged ins.The event date was asked but was unknown.No further complications were reported/anticipated.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Pt rep called and explained pt needed an mri again, but pt hadn't known how to charge the ins since they were first shown how to do so in 2015 or 2016.Pt now needs mri on their hand after an injury and kept 'getting the run around' by the hospital because no one wanted to allow an mri without more info (caller said pt's original implanting doctor was no longer around).Pt was working with hcp.Agent try to follow up with pt to try and pull ins out of possible over discharge mode.

• 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: 9235092
• MDR Text Key: 171598769
• Report Number: 3004209178-2019-20364
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Date Device Manufactured: 02/25/2014
• 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 Sex: Male
• Patient Weight: 78 KG