MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Device Difficult to Program or Calibrate (1496); Shipping Damage or Problem (1570); Data Problem (3196)

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

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_wrench_acc.Product type: accessory.Product id: a610, product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the doctor tried 3 different clinician tablets when trying to transfer the settings from the previous implantable neurostimulator (ins) to the new ins and was getting the message "invalid data: invalid data has been detected.All annotations and session history will be cleared." the doctor ended up abandoning trying to use the ins that was intended to be implanted and tried another ins.Upon trying another ins, the issue resolved.There was no message, the transfer settings function worked as expected and the doctor continued.It was reviewed that the message is typically due to some sort of data that was corrupted and could be in two different locations of the memory.It is not suspected to be an issue with the ins but the unused ins could still potentially be a part of a new case.Additional information was received from the manufacturer representative (rep) stating that the clinician application software version that was used on the 3 clinician tablets at the time of the event was the most current app version 20.03.0.32.The cause of the invalid data message was not determined.The rep indicated that they did not know if the issue was the unused ins or the tablet.The same tablet successfully programmed 4 other ins that same day so they don't believe it was the tablet.Additional information received from the manufacturer¿s representative (rep) reported they ordered the return kit for the healthcare provider (hcp) who would return the device as soon as they received it.No patient symptoms or further complications were anticipated.Additional information received from the manufacturer¿s representative (rep) reported the implantable neurostimulator (ins) was returned to them yesterday.No patient symptoms or further complications were anticipated.(b)(6) 2020 rp (hcp): additional information received from the healthcare provider (hcp) reported they were unable to program the device so it wasn¿t implanted.No patient symptoms or further complications were anticipated.

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.

Manufacturer Narrative

H3.Analysis of the implantable neurostimulator (ins), serial number: (b)(6), found no anomaly.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10029004
• MDR Text Key: 190129484
• Report Number: 3004209178-2020-08167
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; SEE H10
• Patient Age: 58 YR