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)

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

Event Date 01/01/2024

Event Type  Injury  

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.Continuation of d10: product id 97740, serial: (b)(6), product type: 0201-programmer patient; implant date n/a; explant date n/a.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 who was implanted with an implantable neurostimulator (ins).The reason for call was patient reported both the programmer and recharger were not able to make a connection to ins and kept showing the 'synchronize' screen.Patient stated when they press the 'stimulation on' button the screen just blinks and doesn't seem to respond even though both external devices are fully charged.Patient service walked patient through checking the antenna connection and remove/reinsert batteries into programmer, then try pressing synchronize button both with and without the antenna plugged into their programmer.Patient reported seeing check antenna screen, then synchronize screens again after 3 beeps.The issue was not resolved.Agent asked pt the last time they were able to charge and they said about a month and a half ago.Agent understood ins was possibly over discharged and reviewed information with pt.When agent asked event date, pt said the issue began over a month ago but they had trouble getting in contact with patient services.Pt said they also had contact info for a rep so may try reaching out directly as well for appointment.Mdt rep called with patient present in clinic to state they are unable to connect the controller to the patient's ins, and this began a few months ago.Rep states they see a screen that displays the ins with a question mark and a controller symbol.Patient was overheard on the call that their ins has 3/4 of a charge on it and they last charged about a week ago.Rep states she tried a new antenna with the controller, but was seeing the same screen.Rep states the ins is not tilted in the body and the patient was overheard stating they feel that they have to apply pressure to the ins when recharging, as the antenna has "always been tough".When connecting the patient's recharger, they were unable to connect.Ts advised rep to start a physician recharge mode, which they were able to successfully begin.Rep states she did not initially see a por message.Rep plans to complete physician recharge with the patient.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that an overdischarge was confirmed.The difficulty charging and inability to connect was due to the battery being overdischarged.Trickle charge x4.Unable to do clinician reset.Patient's physician stated they would like to replace battery.Patient is awaiting replacement.On 2024-apr-23 additional information was received from the rep.The rep reported the issue is considered resolved.They are awaiting scheduling of battery replacement as patient is due for one, as well as the overdischarge.No surgery date is scheduled yet.

Manufacturer Narrative

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: 18993304
• MDR Text Key: 338899264
• Report Number: 3004209178-2024-08028
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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: 06/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/26/2024
• Date Device Manufactured: 08/03/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male