MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number 37603

Device Problems Break (1069); Unintended Collision (1429); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Device Embedded In Tissue or Plaque (3165); Convulsion/Seizure (4406); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that the patient is incapacitated, patient had a seizure.No further detail since this was from intake nurse.The caller was not with the patient.The patient was redirected to their healthcare provider (hcp) to further address the issue.Additional information received from the healthcare provider (hcp) reported the cause of the seizures and incapacitation was due to falls with a head injury and bilateral hygromas in addition to damaging/fracturing the leads as a result of the trauma.As a result, the patient was prescribed seizure medication and they had their dbs system removed with a retained lead tip.The patient¿s hcp was going to discuss with the neurosurgeon what to do with the retained lead tip and whether reimplantation was an option.See related rr # 3004209178-2023-05313.

Manufacturer Narrative

Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 24-sep-2016, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: 17-oct-2016, udi#: (b)(4).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.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16775880
• MDR Text Key: 313644311
• Report Number: 3004209178-2023-05315
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/20/2023
• Date Device Manufactured: 10/30/2013
• 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): Required Intervention
• Patient Sex: Male