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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 ESSENTIAL TREMOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTIAL TREMOR Back to Search Results
Model Number 37603
Device Problems Electromagnetic Interference (1194); Unintended Collision (1429); Overheating of Device (1437); Battery Problem (2885)
Patient Problems Burning Sensation (2146); Ambulation Difficulties (2544); Paresthesia (4421)
Event Type  Injury  
Manufacturer Narrative
The event date is unknown.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the programmer is showing elective replacement indicator (eri).In 2019-dec, the patient fell.In 2020-apr or 2020-may, the patient fell, their balance was off, feet dragging, and they had a hard time walking.In 2020-jun or 2020-jul, the patient met with a healthcare provider (hcp) for adjustments and they stated the patient may need to get a cane.In 2021-jan, the patient had an mri and they had to stop because it was "overheating".The patient went back on the 15th and they were able to finish the mri.The patient stated that they sometimes feels a tingling sensation since having the mri.When turning the implantable neurostimulator (ins) on after the mri, the programmer showed eri.They will call the hospital to discuss with the hcp.
 
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 received from the consumer reported the implantable neurostimulator (ins) was the device that was overheating.Nothing was done to resolve it, and the consumer continued to live with it.To resolve the tingling sensation and eri code the consumer had it replaced.
 
Event Description
Additional information received from the consumer reported they didn't know which device was overheating.When the consumer was asked what was done to resolve the tingling sensation, they stated they were asked if they wanted a ¿rechargeable or just batteries.¿ after the consumer received a new neurostimulator they were fine.
 
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
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTIAL TREMOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key11217725
MDR Text Key229172401
Report Number3004209178-2021-01239
Device Sequence Number1
Product Code PJS
UDI-Device Identifier00613994761088
UDI-Public00613994761088
Combination Product (y/n)N
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 05/19/2021
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 Date12/28/2018
Device Model Number37603
Device Catalogue Number37603
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/20/2021
Initial Date FDA Received01/22/2021
Supplement Dates Manufacturer Received02/23/2021
05/17/2021
Supplement Dates FDA Received02/26/2021
05/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight122
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