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 Problems Post Operative Wound Infection (2446); Low Oxygen Saturation (2477); Test Result (2695)

Event Date 06/10/2018

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 healthcare provider (hcp) of a clinical study regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had a lung infection post-procedure.The patient¿s oxyhemoglobin saturation fell and blood examination show the high infectious indicators.The patient was hospitalized on (b)(6) 2018, medications were administered along with an oropharynx breather and oxygen face mask.A ct scan on (b)(6) showed the lung infection.The etiology was stated to be a causal relationship to the dbs surgery, and probably related to an underlying condition or disease, and possibly related to the study disease.The outcome of the event was unknown.No further complications were reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported the patient was recovering and the issue was resolving.It was also reported the study disease was possibly related.No further complications were reported as a result of this event.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.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 and confirmed by the hcp.It was reported that the patient weight was not collected for this study.The ins implant dates were noted as (b)(6) 2018.The lung infection was still ongoing.No further complications were reported as a result of this event.Additional information was received.It was reported the issue resolved on (b)(6) 2018.This was the hospital end date as well.No further complications were reported as a result of this event.

• 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: 7614192
• MDR Text Key: 111489737
• Report Number: 3004209178-2018-13747
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169105492
• UDI-Public: 00643169105492
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2018

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: 01/14/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/15/2018; 07/06/2018
• Supplement Dates FDA Received: 07/03/2018; 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR