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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA Back to Search Results
Model Number 37612
Device Problems Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892)
Patient Problems Unspecified Nervous System Problem (4426); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)
Event Date 10/01/2021
Event Type  malfunction  
Manufacturer Narrative
The event date is an estimated date.Please note that this device was used in an off-label manner as it was implanted for dystonia.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient's implantable neurostimulator (ins) has been off since 2019.The patient's dystonia is getting worse now and they wanted to turn the ins back on.The patient attempted to charge and they indicated that the recharger recognized the implant but the ins would not charge.The patient did not have the recharger available at the time of the call therefore, troubleshooting was unable to be performed.The programming manual with information about conducting a physician recharge mode (prm) was sent.
 
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
Additional information was received from a healthcare provider (hcp) reporting that the patient had the deep brain stimulation (dbs) in 2008 and it took months of adjusting before he got a good response.The patient responded well from 2008 to 2017.The patient had the rechargeable ins implanted in 2018 and the physician did not see the patient again until march 2019.In 2017, the patient's symptoms in the legs and hands started to get worse.The patient felt like stimulation wasn't helping him, so in 2019, the patient elected to not use the stimulator.The patient was not able to charge their ins before the ins was in overdischarge sometime last week.The physician recently brought the ins out of overdischarge on 2021-(b)(6) via two prm sessions.They adjusted voltage to one group and the patient stated he wanted to wait to turn stimulation on de to spasms post-adjustment.The patient indicated that since coming out of overdischarge, the "battery will not hold a charge" and finds the ins is discharging rapidly.The patient had charged up friday night and saturday morning, the ins was down to 0%.
 
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.
 
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Brand Name
ACTIVA
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 Key12692933
MDR Text Key278808897
Report Number3004209178-2021-15858
Device Sequence Number1
Product Code MRU
UDI-Device Identifier00643169864238
UDI-Public00643169864238
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H020007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2019
Device Model Number37612
Device Catalogue Number37612
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/21/2021
Initial Date FDA Received10/25/2021
Supplement Dates Manufacturer Received10/25/2021
01/19/2022
Supplement Dates FDA Received11/01/2021
01/19/2022
Date Device Manufactured09/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age51 YR
Patient SexMale
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