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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS Back to Search Results
Model Number 37612
Device Problems Display or Visual Feedback Problem (1184); Delayed Charge Time (2586); Malposition of Device (2616); 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.
 
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
The patient called and repeated information previously reported regarding the left implantable neurostimulator (ins), the left lead, and left extension being replaced.The patient also repeated information regarding difficulty establishing and maintaining a connection with each ins when trying to charge them.The patient stated that they typically charge the inss every other day and it takes hours to get the charge level to increment from 50% to 75% due to the coupling issue.The patient mentioned that the position of the ins was "not optimum" and thought it might have been implanted too deep.They have to push really hard on the wireless recharger to make a connection with each ins.The patient's provider made an appointment for them to see their surgeon to see if they could get the inss repositioned, but the surgeon did not want to do another surgery due to risk of infection.As a result, the patient was told they just have to deal with the coupling issue.The patient mentioned that they had not charged the inss since last friday, and today the charge level was 75% for each ins when they expected the charge level to be 50%.The patient had a lot of difficulty maintaining a connection with the inss during the call, but they eventually were able to get a connection after repositioning the wireless recharger several times.Agent reviewed that the external equipment was working as expected and advised the patient to continue monitoring the ins charge levels.
 
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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
justin ellis
8200 coral sea street ne mvs21
mounds view, MN 55112
7635265677
MDR Report Key18415497
MDR Text Key331716759
Report Number3004209178-2023-26661
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00763000519247
UDI-Public00763000519247
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2023
Device Model Number37612
Device Catalogue Number37612
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/29/2023
Initial Date FDA Received12/28/2023
Supplement Dates Manufacturer Received06/27/2024
Supplement Dates FDA Received07/09/2024
Date Device Manufactured10/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
"SEE H10...."
Patient Age68 YR
Patient SexFemale
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