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); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900); Material Integrity Problem (2978)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name restore; product id 37761 (serial: (b)(6); product type: 0213-recharger; 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.

Event Description

Information was received from a patient (pt) regarding an external device.The reason for call was patient stated they were trying to charge the implanted neurostimulator (ins) last night, but it would not let them charge.Patient mentioned they had an mri scheduled for wednesday, so need ins charged.Patient said the screen was saying something was wrong with the recharger.Patient service specialist asked, patient said they were getting the poor communication screen.Agent asked when pt last charged ins and they said about a month ago; when agent asked event date for when they first realized they couldn't charge ins they said "let's say january 15th." patient service specialist reviewed possible over-discharge with patient and redirected patient to healthcare provider to make appointment with medtronic rep and provided nas phone number.Patient updated address and agent sent email to prs to update and send new id card.Case reopened and reassigned to email the local mdt reps for visibility.Pt repeated information from this case and noted their hcp hasn't been able to get a hold of the local mdt reps when using the nas number.Agent emailed reps and re-directed back to hcp.Additional information was received from a patient(pt) regarding an external device.The caller had a broken desktop charger connector pin and a split belt since today.Patient stated that they met with a medtronic representative today to help with the stimulator and the items broke.Patient mentioned that the belt was broken "before" but it split even more today.An email was sent to re pair to replace the desktop charger and the belt.

Event Description

Additional information was received from manufacture representative.The cause of the over discharge was due to the patient not charging their implant.The actions/interventions taken to resolve the over discharged ins issue was that a reset of the device was conducted and patient over discharge was cleared.The over discharge has been resolved.Patient is reaching eos on their device and recharging intervals are becoming a burden.Patient has requested that hp implant a new telus battery system to replace their old device.Patient would not advise weight at visit.Physician was aware of the issue and agreed that a new battery was the best option for the patient as they had reached close to their years of service and the over discharge degrading the battery quality.Patient requested the new intellis battery and was very happy with this plan.

Manufacturer Narrative

Continuation of d10: product id (b)(4) serial# (b)(6) product type recharger product id (b)(4) serial# (b)(6) product type recharger product id (b)(4) serial# unknown product type recharger h3: analysis of the 37761 desktop charger (dtc) (serial number (b)(6).Revealed a frayed cord.No anomalies were visually observed.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: 18988163
• MDR Text Key: 338751361
• Report Number: 3004209178-2024-07921
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• 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 Age: 51 YR
• Patient Sex: Female