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

Model Number 37601

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

Patient Problems Hyperemia (1904); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 06/22/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) of a clinical study regarding a patient who was implanted with a neurostimulator (ins) for parkinson's disease.It was reported the patient experienced left infraclavicular ins exposure with hyperemia on edge of the ins, which was observed on (b)(6) 2019 and occurred post-procedure.Actions included surgical intervention which involved ins removal on (b)(6) 2019.Antibiotic therapy was also administered and the patient was hospitalized from (b)(6) 2019 to (b)(6) 2019.It was also noted that prolongation of existing hospitalization occurred.The ins was also interrogated and reprogrammed.The event severity was considered life-threatening, but no permanent impairment occurred.Etiology was considered causally related to study procedure and study device.The event was considered resolved as of (b)(6) 2019.No further complications were anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

No additional information was received.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information confirmed the ins was explanted on (b)(6) 2019, which left the leads and extensions abandoned.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from an hcp of a clinical study updated the etiology of the event to clarify it was not related to the study procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from an hcp of a clinical study via a rep indicated there was no reason provided for the lead/extension abandonment by the site.There was no plan to re-implant a new ins and no indication on whether the leads/extensions would be explanted at a later date.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from an hcp of a clinical study indicated no surgical intervention occurred.This contradicts previously reported information.Follow-up will be performed to clarify/confirm if surgical intervention occurred.

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.

Event Description

Additional information was received which reported the patient experienced infection.

• 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 00777
• MDR Report Key: 8881868
• MDR Text Key: 153950373
• Report Number: 3004209178-2019-15365
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/24/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/11/2019
• Supplement Dates Manufacturer Received: 08/13/2019; 12/17/2019; 01/22/2020; 02/11/2020; 03/07/2020; 08/21/2020
• Supplement Dates FDA Received: 08/29/2019; 01/10/2020; 01/31/2020; 02/21/2020; 03/20/2020; 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR