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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 ESSENTI
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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI Back to Search Results
Model Number 37612
Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Pain (1994); Dysphasia (2195); Ambulation Difficulties (2544); Electric Shock (2554); Insufficient Information (4580)
Event Date 02/25/2024
Event Type  malfunction  
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
It was reported that patient (pt) went to turn their stimulation off yesterday for an mri and they got an extreme electrical shock that lasted most of the day.They had to stay in bed all day and could barely walk.It was terrible, but they are feeling better today.Pt said they normally felt a little shock when the doctor has turned therapy off and back on in the office but nothing like yesterday before.Patient was calling today because they have an mri appointment this morning and wanted to make sure the equipment was working as expected.Pt said it showed a picture they did not expect and no words like they were used to seeing.Pt described the icons which meant therapy was off and text mode had been somehow turned off, which patient wanted turned on.Agent worked with patient to try and enable text mode and after trying several times and removing the batteries and pressing all of the buttons to troubleshoot, pt was successful in activating text mode and confirmed stim was off/ok.Patient services (pss) received call from patient from phone 2.Patient reported that after they came home from the mri, they went to turn the ins back on and reported feeling a electrical shock.Patient stated that it felt like she had stuck her finger in a electrical socket.The patient reported that her teeth were terrible and that they can barely talk.The patient stated that when they saw their healthcare provider (hcp) on wednesday, the hcp turned the implantable neurostimulator (ins) settings down because the patient had not been feeling well.Pss had the caller use the patient programmer and patient confirmed that the therapy was turned on and said that the settings are very low.Pss redirected pt to their hcp to further investigate the ins.
 
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 patient turned the implant off before an mri on sunday and felt a shock when turning it off, and then felt an extreme shock when turning it back on.In addition, the patient was feeling a lot of pain in the mouth.It was noted the patient always felt a minor shock when turning therapy off/on, but nothing like this.The patient was redirected to their healthcare provider (hcp).
 
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Brand Name
ACTIVA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
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 Key18793092
MDR Text Key336968816
Report Number3004209178-2024-05842
Device Sequence Number1
Product Code PJS
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 Other
Type of Report Initial,Followup
Report Date 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/28/2019
Device Model Number37612
Device Catalogue Number37612
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/27/2024
Date Device Manufactured02/07/2019
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 Age79 YR
Patient SexFemale
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