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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 37601
Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Loss of Data (2903)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the healthcare provider (hcp) has continued to use the 8840 clinician programmer for quite some time even after tablet was released and therefore, they've reset patient's devices in the past because the patient will go to another hcp and be interrogated with the tablet and then come back to this hcp who then interrogates the implanted neurostimulator (ins) with the 8840.They stated the patient was seen on (b)(6), was asymptomatic and the ins was interrogated with 8840.The manufacturer representative (rep) reports with hcp and it was found that the ins was off at that appointment but patient's programming was retained.The patient was then seen once at university of (b)(6) as part of research study between 21-jan-2021 and 28-may-2021 and again on may 28th.At the (b)(6) appointment, one of the research fellows noticed that ins was again off and they turned it back on.Both appointments for the research study, the ins would have been interrogated with the tablet.The rep stated the patient has been checking the ins daily with the patient programmer (pp) since may appointment and hasn't noticed it being off at all.The patient was seen today by the hcp in office and the ins was off yet again.The hcp viewed usage data which showed that ins has been on continuously except that on (b)(6) 2021, it was only on for about 5-10% of the day and then there is no more data.The rep stated that the patient hasn't reported any therapy issues.They ensured the ins time was synced with tablet time and they reset it to be sure.The rep stated the patient went through how they check the ins with programmer and they appear to be doing it correctly and understand what they are doing (as oppose to pressing buttons erroneously and turning ins off by mistake).The patient used to have significant upper body tremor and even with the ins, the patient hasn't been symptomatic.The rep confirmed that the tablet would have been updated to version 3 right around june 13th.
 
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 account had limited access, but was going to try and schedule something.
 
Event Description
Additional information was received from the manufacturer representative (rep) reporting the cause was not determined.The actions taken was the neurologist turned device back on and instructed patient how to use the patient programmer to check status.The rep reported the issue was resolved.
 
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
MDR Report Key12192547
MDR Text Key262469859
Report Number3004209178-2021-11078
Device Sequence Number1
Product Code MHY
UDI-Device Identifier00643169529786
UDI-Public00643169529786
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
Type of Report Initial,Followup,Followup
Report Date 08/30/2021
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 Date02/14/2019
Device Model Number37601
Device Catalogue Number37601
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/25/2021
Initial Date FDA Received07/19/2021
Supplement Dates Manufacturer Received07/21/2021
08/25/2021
Supplement Dates FDA Received07/22/2021
08/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
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