MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3389-28

Device Problems Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Loss of consciousness (2418)

Event Date 09/29/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant product: product id: 3389-28, lot# 0210116677, implanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

A healthcare professional of a clinical study reported that the patient had a large hematoma with left parieto frontal and engagement sub factorial and medial temporal post-operatively on (b)(6) 2015.The patient did not wake up in post-operative.It was unknown what lead to the event.Imaging was done and was abnormal on (b)(6) 2015.There was prolongation of existing hospitalization and emergency room visit.Therapy was suspended on (b)(6) 2015.The issue was not resolved, the event is ongoing as of (b)(6) 2015.The patient's medical history included hypertension, thyroid disorder, and parkinson's disease.This was related to the procedure.Reference manufacturer's report number 2649622-2015-13284.

Event Description

Additional information received reported the event was still ongoing and the patient was still hospitalized since surgery.

Manufacturer Narrative

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 received reported the outcome was unresolved at the time of study exit/death/study closure.It was unclear which was meant and follow-up will be performed to clarify.

Manufacturer Narrative

Upon review of the additional information received, it was determined that (b)(4) no longer applies as (b)(4) was added.

Manufacturer Narrative

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 a health care provider (hcp) of a clinical study via a manufacturer representative (rep).It was reported that the patient was exited from the study because all of the enrolled devices were inactive as of (b)(6) 2016.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5177203
• MDR Text Key: 29232065
• Report Number: 2649622-2015-13285
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2019
• Device Model Number: 3389-28
• Device Catalogue Number: 3389-28
• Device Lot Number: 0210102998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• Date Device Manufactured: 08/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 00053 YR