MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 06/07/2020

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3389s-40, serial#: unknown, implanted: (b)(6) 2020, product type: lead.Product id: 3389s-40, serial#: unknown, implanted: (b)(6) 2020, product type: lead.Product id: 3708660, serial#: unknown, implanted: (b)(6) 2020, product type: extension.Product id: 3708660, serial#: unknown, implanted: (b)(6) 2020, product type: extension.Product id: 3389s-40, serial/lot #: unknown.Product id: 3389s-40, serial/lot #: unknown.Product id: 3708660, serial/lot #: unknown.Product id: 3708660, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient received a deep brain stimulation (dbs) therapy on (b)(6) 2020.The surgery was successful on the day of the surgery, and there was no abnormality in the postoperative nuclear magnetic resonance review after the surgery.On (b)(6) 2020, the ct showed that the patient had hemorrhage in the cerebral cortex.Considering the patient's age, the hospital took conservative treatment.On the 8th, ct showed no increase in bleeding.The patient currently has no serious adverse reactions, and the family members have a more rational attitude.The hospital still adopts conservative treatment, and we will continue to pay attention to it.Additional information was received stating that the patient was scheduled for surgical rescue.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id: 3389s-40, serial# unknown, implanted: (b)(6) 2020, product type: lead.Product id: 3389s-40, serial# unknown, implanted: (b)(6) 2020, product type: lead.Product id: 3708660, serial# (b)(6), implanted: (b)(6) 2020, product type: extension.Product id: 3708660, serial# (b)(6), implanted: (b)(6) 2020, product type: extension.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

Additional information was received from the manufacturer representative (rep) stating that it was unknown if the cerebral cortex hemorrhage had resolved and the patient weight could not be provided due to patient privacy.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• MDR Report Key: 10209540
• MDR Text Key: 198720223
• Report Number: 2182207-2020-00438
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR