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

Model Number 37612

Device Problems Low impedance (2285); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot#: va24afn, implanted: (b)(6) 2020, product type: lead.Product id: 3387s-40, lot#: va24afn, implanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 08-oct-2022, udi#: (b)(4).Product id: 3387s-40, serial/lot #: (b)(4), ubd: 08-oct-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacturing representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had low impedance on bipolar 2-3 contact pair in left lead intraoperatively.There appeared to be a bent or kink in the lead during boot removal in stage 2 at contact 3.Upon impedance check, it was confirmed that there was low impedance at contact 2-3 pair.The session report showed an x and low at contact 2<(>&<)>3.Impedances were double checked with the same result.The healthcare professional did not mark the leads during stage 1 so he will be unable to confirm if it was the left or right lead that had low impedance, even though the session report shows left lead.The issue was not resolved at the time of report.No symptoms were reported.No further complications were reported/anticipated.Additional information was received from the manufacturer representative (rep) reporting that the procedure was a stage 2 initial implant placement of the battery after the stage 1 that was 2 weeks prior.The leads were not connected prior to the damage.They were connected as part of the stage 2.It was confirmed that the lead was bent or kinked.The cause of the low impedances was not determined.Actions/interventions included drying off the ins and lead and extensions.The low impedances did not resolve.This was confirmed with the physician.

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.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: 9764114
• MDR Text Key: 181543226
• Report Number: 3004209178-2020-04199
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 27