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

Model Number 37601

Device Problems Premature Discharge of Battery (1057); Failure to Deliver Energy (1211); Unintended Collision (1429); No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia and movement disorders.It was reported that the ins voltage is at 2.49 with an end of service message (eos).The caller was requested to use the 8840 to read the ins and voltage with the 8840 is 2.50.Unable to turn on ins and patient has lost therapy benefit.It was reviewed that they are unable to turn on after eos when voltage is at eri range.Caller was asked to send the ins in for analysis for premature eos.Patient indicates never turning off ins.Impedances were elevated on left side with the tablet and normalized with the 8840.The therapy impedance left side was 1,030 ohms and right side 1158 ohms.No shorts or lower value noted.The caller mentioned the patient had a fall and they hit his right side head above eyebrow approximately 3 weeks ago.Patient was seen (b)(6) and battery voltage was 2.53v.They scheduled a replacement surgery end of (b)(6) and the rep is going to speak to the healthcare provider to get replaced sooner if possible.It was reported to be a sudden change in therapy/symptoms.No further complications were reported or anticipated with this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep) reporting that the patient was referred to his neurosurgeon and is scheduled to have their device replaced on (b)(6) 2019.The cause of the end of service and loss of therapy was not determined.The issue is not resolved yet.The device is reported to be explanted on (b)(6) 2019 and is expected to be returned for analysis.This information was confirmed by the physician.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative (rep) indicating that that device was returned and the device went into end of service before it should have.The device depletion was prior to 2.2 volts eos.Initial settings provided included 4.5 volts, pulse width 210 and rate 120.Usage was 24/7.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (serial # (b)(4)) revealed the battery was at normal end of life and the t elemetry and output were okay.Fdd code 1057 no longer applies.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.

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: 8241849
• MDR Text Key: 132871861
• Report Number: 3004209178-2019-00818
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR