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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 37602
Device Problems Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Patient Device Interaction Problem (4001)
Patient Problems Burning Sensation (2146); Electric Shock (2554)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the implanted neurostimulator will heat up even when not in the sun or doing anything and patient was initially getting electrical shocks when positioning themselves in bed to go to sleep, but those have since resolved.Caller didn't know when these sensations started but got the impression they started around the same time even though the shocking has since resolved.The patient saw the healthcare provider prior to day of provider x-rays were ordered and patient was seen for follow-up appointment.At appointment, impedances were tested and measured less than 250 ohms on c-1 and that everything else was "within normal limits".Caller stated later specified that provider stated all the other case pairs were between 250-2000 ohms.X-rays showed no obvious issues with wire.Caller assumed x-rays were taken of the entire system (including the ins) but wasn't sure.Caller wasn't provided any other specific impedance results, any therapy settings or status of patient's therapy.
 
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 manufacturer¿s representative (rep) reported the patient was scheduled to be seen by their physician on october 4th fur troubleshooting.Further information would be available at that time.
 
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 manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported the patient was no longer having the shocking sensations, but still reported a slight heating in the left chest where the neurostimulator was located with the heating sensation localized to the chest.The impedances measured at 3.0 v were within normal limits with the only time an open impedance (only on one electrode-electrode 1 results of 247) was noted was when the rep pulled slight traction on the neurostimulator in the chest and was positional.The hcp discussed the options of replacing the neurostimulator and/or the extension during a troubleshooting surgery as they felt the impedance and heating sensation may be fixed by replacing the neurostimulator.The patient wanted to think about the extra procedure.The other option would be to troubleshoot when the patient was due for a routine battery replacement (their current implant was at 2.94v).
 
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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
MDR Report Key12413743
MDR Text Key269528113
Report Number3004209178-2021-13274
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00763000100346
UDI-Public00763000100346
Combination Product (y/n)N
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/14/2021
Device Model Number37602
Device Catalogue Number37602
Was Device Available for Evaluation? No
Date Manufacturer Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight127
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