MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number B35200

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Shaking/Tremors (2515)

Event Date 01/03/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, serial/lot #: unknown.The event date is an estimated date.If information is provided in the future, a supplemental report will be issued.

Event Description

The caller reported that the patient has been "shaking like a leaf" for 4 days.At the same time they noticed their tremor, the patient was getting an error message in the dbs therapy app that said 'out of range.Contact your clinician.The neurostimulator is providing less than the requested therapy.Service code: 1703.' after getting the 1703 service code, the caller stated that they tried to increase stimulation but ended up getting a similar error message, except the service code was 1098.During the call, agent had the caller open the dbs therapy app and check the ins status.The caller confirmed that the ins battery is ok and the therapy is on.Agent consulted with technical services and they confirmed that the 1098 service code is also an 'out of range' error message.Agent reviewed the meaning of the error messages.The caller was redirected to the patient's healthcare provider to further address the issue.Additional information was received from the consumer reporting the cause was identified.The event was resolved.They reprogrammed to circumvent broken lead #1 and continued contact with the hospital.

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
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11325078
• MDR Text Key: 243691378
• Report Number: 3004209178-2021-02549
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00763000253363
• UDI-Public: 00763000253363
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 78