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

Model Number 37612

Device Problems Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892)

Patient Problems Convulsion, Tonic (2223); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id 37651, lot# serial# (b)(4), product type recharger.Product id 37761, lot# serial# (b)(4), product type recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the recharger will not charge the implant.The patient had a return of symptoms 1.5 weeks ago.Additional information received from the consumer their dog destroyed the recharger and desktop charger.The consumer couldn¿t get the implant to charge since about a month and a half ago and they had a return of symptoms such as their ¿neck going crazy¿ making it hard to look at the phone and not being able to eat.An appointment was scheduled with the healthcare provider (hcp) for (b)(6) 2021 to get the implant jump started which had happened once before.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the patient contacted them.The rep explained it sounded like an overdischarge, but they couldn't help them out of state.The rep contacted a local rep who recommended a physician and were going to meet with the patient at their first appointment.

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 (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: 12804649
• MDR Text Key: 280704389
• Report Number: 3004209178-2021-16934
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/17/2021
• Date Device Manufactured: 08/08/2018
• 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
• Treatment: SEE H10
• Patient Sex: Male