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

Model Number 37601

Device Problems High impedance (1291); Low impedance (2285)

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

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 3387s-40, lot#: va13xcf, implanted: (b)(6) 2016, product type: lead.Product id: 3387s-40, lot#: va14ffq, implanted: (b)(6) 2016, product type :lead.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2016, product type: extension.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2016, product type: extension.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 16-nov-2018, udi#: (b)(4) ; product id: 3387s-40, serial/lot #: (b)(4), ubd: 17-dec-2018, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 27-feb-2020, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: 27-feb-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was implanted with a neurostimulator (ins) for dystonia, movement disorders.It was reported that during pre-op for routine battery replacement they ran impedances and the results were out of normal range on bilateral lead on the right battery side.There were no signs or symptoms, or loss of efficacy reported by the caregiver.With normal pre-op testing high impedances noting with the right battery only.Therapy impedances were out of normal range.They re-interrogated and impedances resulted the same.The rep contacted the doctor to find out if it was a known issue and they confirmed that it was a known issue.The results were reported to the doctor prior to surgery.The doctor proceeded with bilateral replacement.Intra-op impedances remained out of normal range consistent with pre-op findings.The doctor was aware of continued impedances out of normal range involving therapy settings used for right dbs battery and they instructed to leave the dbs therapy on with no change to thera py settings.The issue was not resolved at the time of the report.There were no further complications reported.

Manufacturer Narrative

Other applicable components are: product id 37601 (b)(4).Product type implantable neurostimulator product id 3387s-40, lot# va13xcf, implanted: (b)(6)2016 product type lead product id 3387s-40 lot# va14ffq implanted: (b)(6)2016 product type lead product id 3708660 (b)(4) implanted: (b)(6)2016 product type extension product id 3708660 (b)(4)implanted: (b)(6)2016 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 cause of the impedances were unknown.While in the or multiple impedance tests were performed and per the md the extension was dry and fully seeded inside the header.Impedances out of normal were consistent in preop impedances.The right-side ins was replaced, but the account had disposed of the previous ins so it wouldn¿t be returned for analysis.There were no further complications reported.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3387s-40, lot# va13xcf, implanted: (b)(6) 2016, product type: lead; product id: 3387s-40, lot# va14ffq, implanted: (b)(6) 2016, product type: lead; product id: 3708660, serial# (b)(4), implanted: (b)(6) 2016, product type: extension; product id: 3708660, serial# (b)(4), implanted: (b)(6) 2016, product type: extension.If information is provided in the future, a supplemental report will be issued.

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: 8768544
• MDR Text Key: 150304476
• Report Number: 3004209178-2019-13076
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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,Followup,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 07/05/2019; 07/16/2019; 11/10/2020
• Supplement Dates FDA Received: 07/08/2019; 07/26/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 12 YR