MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT

Model Number B35200

Device Problem Electromagnetic Interference (1194)

Patient Problems Pain (1994); Shaking/Tremors (2515)

Event Date 05/01/2021

Event Type  malfunction  

Event Description

It was reported that they had an mri in (b)(6) 2021 unrelated to implant and since then, the therapy is not working well.The therapy off time is longer so the patient is in pain and having tremors.The patient states she thinks the implantable neurostimulator (ins) was turned off before the mri and on because there was a manufacturer representative (rep) there.Their physician mentioned not being able to fine tune the settings.They are trying to figure out what is wrong.

Manufacturer Narrative

The event date is an estimated date.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the consumer reported the deep brain stimulation (dbs) unit wasn¿t working successfully so it was off a lot as there was little control of symptoms.

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.

• Brand Name: PERCEPT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12598487
• MDR Text Key: 281268774
• Report Number: 3004209178-2021-15075
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 98