MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37602

Device Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 37602, serial #: (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator.Product id: 7482a51, serial #: (b)(4), product type: extension.Product id: 7482a51, serial #: (b)(4), product type: extension.Other relevant device(s) are: product id: 7482a51, serial/lot #: (b)(4), ubd: 07-nov-2012, udi #: (b)(4).Product id: 7482a51, serial/lot #: (b)(4), ubd: 07-nov-2012, udi #: (b)(4).Refer to manufacturer report #3004209178-2019-03484 for details pertaining to the related reportable event.If information is provided in the future, a supplemental report will be issued.

Event Description

On 2019-feb-18 (b)(4) (rep): information was received by a manufacture representative (rep) regarding an implantable neurostimulator (ins) for dystonia, movement disorders.It was reported that the rep had called in because they were reviewing registration information as the patient was going to have their ins and extension replaced.The patient had a fall and when they would turn their head to the left they felt shocking on the right side up behind their ear.The patient was in the office on thursday and the caller checked the impedances which were all fine.The caller stated the surgeon didn¿t have the chance to review anything until friday.There were no further complications reported.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 37602, serial# (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator; product id: 7482a51, serial# (b)(4), product type: extension; product id: 7482a51, serial# (b)(4), product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the patient was walking their dog and they pulled the patient hard causing them to fall.It was unknown if the shocking had resolved at the time, but more information could be gathered at their follow up appointment, which wasn't scheduled yet.It was also stated that the patient had products removed and then replaced.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturer¿s representative (rep) reported they had no further information from updates from pathology.No further complications were anticipated.

Manufacturer Narrative

Section 'device' information references the main component of the system and other applicable components are: product id :37602, serial# (b)(4), implanted: (b)(6) 2018, product type: implantable neurostimulator; product id: 7482a51, serial# (b)(4), product type: extension; product id: 7482a51, serial# (b)(4), product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received: it was reported that the rep had requested the explanted right extension and right battery from the hospital, so it could be returned.They hadn't received a call from pathology to say it was ready to be picked up but would follow up with the hospital.There were no further complications reported.

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.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8350103
• MDR Text Key: 136486567
• Report Number: 3004209178-2019-03487
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/06/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 02/19/2019; 02/27/2019; 05/09/2019; 10/06/2020
• Supplement Dates FDA Received: 02/27/2019; 03/13/2019; 05/16/2019; 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention