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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problems Fall (1848); Complaint, Ill-Defined (2331); Alteration In Body Temperature (2682)

Event Type  Injury  

Manufacturer Narrative

The event date is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient was found on the floor and patient that he did not charge himself up.On the day of the report, the caller checked on the patient and they had peed everywhere and was laying there with his eyes always wide open majority of the time.Caller thinks it is because of the muscle relaxers the doctor gave to the patient, and the caller noted they have to call the hospital because the patient looks like he had taken too much medication.The patient's hands and legs were ice cold.The caller did not like the way the patient was staring in to space.Patient is afraid to go to the hospital because they (the medical staff) "get mad at the patient because they don't know how work with" the device and equipment.It was stated that the medical staff "charge up the patient and he comes home fine.Caller still wanted to review the charging/ it was reviewed and confirmed that the patient was charging the implantable neurostimulator (ins) and has excellent coupling and they were using adhesive discs.It was stated that patient has been charging all day, patient confirmed he should charge every day but does not, however, it was noted that patient sounded to not be in good condition to be answering questions.Patient was redirected to seek medical assistance as deemed best.Additional information was received from a manufacturer representative (rep) on (b)(6) 2020 stating the rep saw the patient in the hospital after this report.The rep got a page that the patient was moved to a rehab center.Additional information was received from a manufacturer representative (rep) on (b)(6) 2020 stating that the patient was in the hospital because the patient has multiple co-morbidities as his parkinson's disease progresses and his ins was off.The rep turned it on at the hospital and instructed staff how to charge.Additional information was received from a manufacturer representative (rep) on (b)(6) 2020 stating the cause of the ins being off was due to insufficient charging.Additional information was received from a manufacturer representative (rep) on (b)(6) 2020 clarifying that the patient was admitted to the hospital and has been discharged to a rehabilitation center.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported they met with the consumer and at that time the healthcare provider (hcp) recommended the consumer be placed in a nursing or rehab facility.The rep.Stated the consumer¿s implantable neurostimulator (ins) was depleted on (b)(6).The rep.Spoke with a nurse and reviewed how to charge and recommended that the hcp keep the patient on a charging schedule of daily charging.Since that time the rep.Didn¿t know where the consumer was staying as they had been at a relatives for some time following care in a facility.No troubleshooting was required related to the issue.No 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.

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.

Event Description

It was reported the patient is in the hospital.The recharger is with the patient but the a/c adapter is missing.The rep assumes the recharger is dead.When the healthcare provider (hcp) tried to connect using the patient controller, they are getting information that the rep could not identify.The hcp described a question mark and a phone.The rep had them press the navigation key and that did not resolve the issue.Technical services reviewed information about the poor communication message.The rep indicated they have seen the patient within the past 6 weeks and the implantable neurostimulator (ins) was not depleted at that time.The caller will follow up with the hcp to try to identify the screen that is being displayed.Additional information received from the manufacturer¿s representative (rep) reported the patient fell resulting in hospitalization, but the rep.Was unsure if it was device related.The cause of the poor communication message was due to the patient programmer (pp) not being directly over the implantable neurostimulator (ins).To resolve the issue the pp was placed properly over the battery in the chest and a reading was achieved.However, due t o lack of charging the battery was turned off.It was noted the ac cord was missing from the recharger, so a new cord was sent out to charge the system resulting in the battery being turned back on.No further complications were anticipated.

• 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: 9962086
• MDR Text Key: 187904320
• Report Number: 3004209178-2020-07203
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 77