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

Model Number 37603

Device Problems Low impedance (2285); Electromagnetic Compatibility Problem (2927); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2023

Event Type  malfunction  

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.

Event Description

It was reported that the patient's programmer showed oor.The caller reported the patient in december was programmed to c+, 0-,1-,2- and battery voltage was 2.83v.Battery voltage was 2.85 in october, so not a significant battery drain.Patient is out of the country currently, and appears to have lost therapy (symptoms coming back strong).Some information is not known yet, such as when the issue occurred (except recently).Caller wanted to discuss if replacement of ins should be done as soon as possible.Discussed unknown until impedances can be checked and /or reprogrammed.Caller mentioned patient had additional groups and will suggest to patient to change groups to see if therapy can be re-established.Patient programmed to 1.8v, 90pw, and 130 rate.Impedance was 373 ohms / 4.5ma.Additional information received from the healthcare provider (hcp) reported they patient had breast augmentation surgery out of the country and the dbs device wasn¿t turned off for it.During the procedure there was potential an electrocautery instrument ¿surged¿ and/or there was ¿feedback¿ on one of the instruments/machines being used, but they didn¿t believe anything touched the implant.Shortly after the procedure the patient noticed an oor message and a return of symptoms.The patient changed from the oor group which provided the best therapy to a different group which resolved the oor, but wasn¿t as beneficial.Battery voltage is currently 2.78v and therapy impedance on the oor group is 366 ohms/4.6 ma.The hcp stated that electrode impedances were all green with lowest monopolar value at contact 3 at 658 ohms and lowest bipole pair at 2-3 at 864 ohms.Therapy impedance on the less effective, double monopolar program was 469 ohms.Tss had caller use tablet to activate oor group, turn amplitude to 0v and increase to see if oor would appear but caller was able to increase to 2.4 ma without any alerts.It was reviewed it was unlikely the surgery led to the oor, but speculated the oor may be due to low therapy impedance and as the implant depleted it was hard for the implant to deliver therapy.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (M
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16370482
• MDR Text Key: 309496670
• Report Number: 3004209178-2023-02038
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Date Device Manufactured: 09/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female