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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Dysphasia (2195); Malaise (2359); Shaking/Tremors (2515)

Event Date 02/05/2024

Event Type  malfunction  

Event Description

Information was received from a patient regarding an external device, wireless recharger (wr).The reason for call was patient (pt) reported that the wr stopped working over the weekend.Patient said the wr would connect to the implant but then go to the 'not found' screen.Patient said they had dropped the wr twice recently.Pt also mentioned that the implant battery had turned off because it depleted and the patient had started shaking, pt was able to charge implant back up and turn therapy on.Pt said they had charged the implant up to 100% and within 2 hours the implant charge dropped down to 25%.Pt said this wasn't normal for them.Pt said in (b)(6) 2024 they went to the healthcare provider (hcp) and the manufacturer representative (rep) increased the dbs settings but they hadn't noticed the implant battery depleting quicker until this morning.During call the wr started showing that it was charging the implant but the recharger app was showing recharger not found.Wr was hard reset during call but recharger app still showed recharger not found.Once handset was powered off and back on and then the recharger app showed implant at 50% with excellent recharge quality.Pt mentioned that "for weeks" they had not been able to get to charge complete.Patient services (pss) reviewed information about recharge time.Pt said they were going to try to charge up implant to charge complete after troubleshooting was done and would call ps back if they ran into issues.If pt calls back in and has encountered more issues please replace wr.  the patient's son called and repeated information regarding the wr charging the ins slowly, noting that it took hours to get the ins to charge 25%.The caller repeated that the wr was replaced and this morning the replacement wr got the ins fully charged within an hour.The caller also repeated the patient's concern regarding the ins charge level dropping from 100% to 75% within an hour.The caller also mentioned that the patient was having difficulty speaking at the time of the call, but it was unclear if that was related to the mdt device/therapy.The caller was advised to call patient services to get suggestions for the ins battery depleting rapidly.Agent redirected the caller to the patient's hcp to further address the issue.The caller said the patient has an appointment pending, they are just waiting for confirmation that a rep will be present at the appointment.Pt called back from phone number on file saying the new wr worked and got the implant charged up to 100% quickly, pt said they had implant at 100% and kept charging for an additional hour.Pt said they still had an issue with the implant battery draining too quickly because an hour later the implant was down to 75%.Pss redirected pt to hcp to check implant (to investigate implant battery depleting too quickly).Patient called back and had received wr replacement.Caller asking for instruction.Pss reviewed recharger app.Caller also changed the time on the handset.Caller stated ins is showing good connection and has went from 50% to 75%patient and patient rep called back stating recharger has been charging ins for 2 hours from 50-75% and charge does not advance.Caller stated informing  rep yesterday morning.Pss emailed repair to replace the wr.Pss reviewed for patient to continue checking ins charge level so therapy does not turn off.  the healthcare provider (hcp)  reported patient has an appointment scheduled tomorrow at hcp office.Caller reported for the past 3 days, patient is feeling horrible as the ins is not able to hold a charge.

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.Continuation of d10: product id wr9200 (serial: (b)(6)product type: 0213-recharger.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information received from the consumer reported the circumstances that led to the recharging and depletion issue was due to a change in the device setting.The physician rerouted it which solved that, but now there was a new issue they had an appointment for.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 18798578
• MDR Text Key: 337626390
• Report Number: 3004209178-2024-05907
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2024
• Date Device Manufactured: 01/25/2021
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 120 KG