MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Air Embolism (1697); Cardiopulmonary Arrest (1765); Death (1802); Seizures (2063); Coma (2417); Loss of consciousness (2418)

Event Date 10/22/2017

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: product id: 37601, serial (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with a neurostimulator for dystonia and movement disorders.It was reported that the patient was getting their old system removed and having a new one put in but did not survive the surgery and died in the medical facility.It is assumed that the system was left in once the patient died.Additional information received from the healthcare professional (hcp) on feb-24 clarified the event.Intraoperative seizures were witnessed during the "awake" lead implant which led to a loss of consciousness and cardiopulmonary arrest.Cpr was attempted which resulted in a return of spontaneous circulation but persistent coma/seizure.The mechanism of death remains unclear per the autopsy.No hemorrhage was seen but there was abundant amyloid deposition consistent with alzheimer's disease.Air embolisms could not be ruled out.The death was observed one week post op in the icu after withdrawal of life support due to persistent seizures and coma.No further complications are anticipated.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7465351
• MDR Text Key: 106640664
• Report Number: 3004209178-2018-09373
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934604
• UDI-Public: 00613994934604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2018
• Date Device Manufactured: 04/26/2012
• 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): Death; Other
• Patient Age: 59 YR