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

Model Number 37612

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

Information was received from a patient regarding two wireless rechargers (wr).The patient reported difficulty staying connected to ins when recharging and being unable to connect to the recharger application.Pss had the caller ensure that the bluetooth and location services were on.Pss had the caller restart the handset and reset the first wr (ending in 18).After the reset, pss had the caller attempt to connect the wr to the ins, but the wr kept intermittently connecting to the ins.The caller reset the wr off the docking station, but the issue persisted.The wr (ending in 18) would not connect to either of the patient's implants.Pss had the caller attempt to connect the second wr (ending in 77) to the ins, but the wr was intermittingly connecting to the ins.Pss had the patient reset the wr on and off the docking station and attempt to connect to the ins.After the caller reset the wr on the docking station, they could maintain a good connection between the ins and the wr.The caller confirmed they could connect to the recharger application and stated that the ins was 75% charged.Pss sent an email to repair to replace the wr (ending in 18).No symptoms were reported.Additional information was received from the patient on 2023-dec-01 that they received the new wr, and they couldn't connect it to the left implant and maintain the connection. during the call, the patient immediately connected to the right ins but had trouble connecting with the left ins.However, they could connect to wr and the recharger app once repositioned. the pt had trouble staying connected to the left implant, and pss had them hard reset the new wr for good measure (pss doesn't suspect an issue with the new wr). they used the other wr and had to reposition the other wr over the implant many times to get a connection to the implant; once the new wr was reset and repositioned, they could start the charging session on both implants.Pss redirected the pt to their hcp to have both implants checked as they said it was difficult to find both implants to charge them, especially the left implant. pt will be using the new wr and noting if it has issues connecting with implants and sharing with hcp. when asked if they had any changes at their implant site, they said they "had a lot of fat" over their implants. pt mentioned that the rechargeable devices were implanted on 3/6/2023, so they had swelling at the implant site from the implant procedures (see rtg0414785 for the swelling report). the patient said that their left implant battery was removed and replaced with a new implant, and the left extension was removed on 07/10/2023 because the patient had an infection (see mpxr 1044760 for the infection in the right ins/extension report and removal/washout scheduled).During the surgery, it was determined the lead was damaged and needed to be replaced (see mpxr 1076933 for the report of the damaged lead, impedance, and scheduled lead and extension replacement surgery). pt said that hcp went back in for surgery on (b)(6) 2023 because "the connector" in their head was damaged, "part of it had been dissolved," so the old new connector (extension) and lead were removed and a new lead and extension were put in (see dtrak 00021705037108 for the report of the damaged lead removed). pt added that hcp said they had "some fluids" in the line; pt didn't know what the hcp had meant by this.They said they went back to their hcp on monday (b)(6) 2023, and that's when they were told about the fluid.Pt said the doctor talked to the programmer, and they concluded that fluid was in the lines.The patient said they didn't know what the hcps meant by this and would fu with hcp regarding both implants being difficult to charge.

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: 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: 18415497
• MDR Text Key: 331716759
• Report Number: 3004209178-2023-26661
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000519247
• UDI-Public: 00763000519247
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2023
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2023
• Date Device Manufactured: 10/13/2022
• 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 Age: 68 YR
• Patient Sex: Female