MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INS B35300 PERCEPT RC V1; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number B35300

Device Problems Failure to Deliver Energy (1211); 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 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id wr9230 ,serial# (b)(6), product type recharger.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

It was reported that the patient was implanted on the (b)(6) in 2024 and had very good therapeutic effect.Handling of the recharger and handset was well known due to a previous implanted activa rc implantable neurostimulator (ins).Patient had a regular battery depletion of approximately 25% every 24 hours and was recharging daily.Recharge quality was always "excellent" according to the recharger application.On wednesday (b)(6), the patient could recharger to 100% without any problems.On friday, (b)(6), the patient got the warning 643 (therapy off due to battery depletion).Since then, the ins could not be recharged at all and telemetry was also not available. when the patient placed his recharger over the ins, the recharger started open-loop charging ( patient described the according screen on the application ) and after exactly 20 minutes he gets the warning message 4101.The patient tried to recharge several times over the weekend.On tue, (b)(6), the patient was seen by a manufacturing representative (rep).The open-loop recharging with error 4101 was confirmed by the sales rep. another rs6230 was used with the same result.The ins could not be interrogated with a ct900.A device reset via the a610 app was tried but unsuccessful. exact reason for the issue could not be determined, therefore it could not be resolved as of now. percept rc with over-discharge can not be recharged.System enters open-loop charging and then stops after 20mins with error 4101. recharger was temporarily replaced with another unit during the troubleshooting with the sales rep.Same issue with the new unit.The issue could not be resolved yet, and it is unknown if it is related to the rs6230.It is unknown if there are any patient/external/environmental factors contributing to this issue.No symptoms were reported.

Event Description

Additional information was received from the manufacturer representative (rep) that surgery is planned for the (b)(6).It is unclear if the doctor will have an x-ray for better planning

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: INS B35300 PERCEPT RC V1
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 18866825
• MDR Text Key: 337639463
• Report Number: 3004209178-2024-06621
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B35300
• Device Catalogue Number: B35300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Date Device Manufactured: 12/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention