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

Model Number 97714

Device Problems Failure to Interrogate (1332); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: date is approximate.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 failed back surgery syndrome and spinal pain.It was reported that the patient asked to have a manufacturer representative (rep) meet them at their appointment on monday to recharge the ins as the ins was completely dead.The patient said it had been a while since they last charged, probably a month ago.The patient said about a month ago they were having trouble charging the ins, so they put it aside, and then when they tried again a couple weeks ago the ins was completely dead and confirmed they were not able to connect anymore.The patient clarified that the charging issues they had were that it was really hard to get the antenna to connect to the ins, and then charging would take longer and the patient said the battery would drain a lot faster (patient services was unsure if recharger or ins battery).The patient stated they would have to keep moving the antenna around as the coupling boxes would keep going down.The caller was redirected to repair for a replacement antenna due to the prior charging issues before the ins went dead, and then patient services emailed the rep field team per the patient's request to try and get the ins charging again/address possible overdischarge.

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

Additional information was received.Pt called back and confirmed they received the replacement recharger antenna and met with their mdt rep yesterday to get their implant started again.Now, pt said for the last few days they have been having problems with their patient programmer.Pt said that tandy told them to call for a new pt programmer.Pt said they had trouble getting the pt programmer turned on, and then it took a long time to get "normal stuff" to come up on the screen.Pt described seeing an informational screen with a battery and something pointing to a controller; it was understood this was possible the poor communication screen.Pt said that the pt programmer will work for a few minutes and then it will stop working.Patient was asked if they were using the programmer antenna, but pt answered by saying they had used the recharger to turn their implant back on, and they couldn't use the programmer to do that.Pt said they could put the pt programmer into mri mode so they could see their mri eligibility.Pt confirmed seeing fu ll-body mri eligibility.Manufacturer representative also reported the patient was able to charge normally after receiving their new recharging paddle.No actions/interventions were taken to resolve the ins draining faster, the ins battery being depleted, the charging issues and the connection/coupling issues once they received the new paddle.Manufacturer representative reported the ins battery depletion and charging issues were reportedly resolved.

• 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
• MDR Report Key: 12542207
• MDR Text Key: 273644783
• Report Number: 3004209178-2021-14524
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR