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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Dysphasia (2195); Shaking/Tremors (2515); Insufficient Information (4580)

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

Patient rep states patient has been having ongoing problems with recharging.Rep has been troubleshooting this issue for months and its gotten to the point where patient has been trying to charge for the past 4-5 days almost continuously and will only charge implantable neurostimulator (ins) to 20%.Rep states when patient charges, the coupling boxes go in and out.Patient will go from 3 to 8 coupling boxes and will not stay.Patient has been able to charge it up eventually but now ins is only at about 20%.Rep states they just had desktop charger replaced and that did not help.Patient had recharger antenna replaced previously also.Rep states current recharger antenna is not damaged.Patient service specialist (pss) asked if patient has had any recent falls and rep stated no.Patient said that at their healthcare provider (hcp) appointment on feb 1st, they noticed therapy was off.Patient was feeling some symptoms and they turned it back on.They don't know why the therapy was off.Patient has cerebral palsy and when patient tries to talk with their finger, it is a lot harder for patient to talk.Patient is more shaky and harder to touch what they need.Rep states be ing with patient a few months back and doctor was adjusting it, going higher, trying to find the right settings for patient.Rep said they spoke to the doctor on feb 1st about having a hard time recharging but he they didn't notice anything except therapy is off.During the call, patient was able to get 6-8 coupling boxes shaded and recharging with good coupling.Rep states recharger shows the ins is only charged to about 20%.Rep confirmed recharger showed lightening bolt- therapy on.Pss was going to reach out to rep regarding transitioning to wireless recharger (wr), but called patient rep back that due to patient's therapy being so low, pss will order recharger replacement.Pss emailed repair to replace recharger.Pss redirected patient to hcp if coupling issues persist.

• 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: 18837661
• MDR Text Key: 337016932
• Report Number: 3004209178-2024-06288
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Date Device Manufactured: 09/12/2018
• 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 Sex: Female