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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 Failure to Interrogate (1332); No Device Output (1435); Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Manufacturer Narrative
The event date is an estimated date.Information references the main component of the system.Other relevant device(s) are: product id: 37092, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that¿a few weeks ago, they noticed that patient programmer (pp) was taking longer to communicate with the implantable neurostimulator (ins).This morning, the pp would not communicate with the ins at all and the patient was seeing a screen with an "antenna and a person with a little 'i'." as a result, the patient was not able to turn their ins back on.They explained that the patient turns their ins off every night.They have contacted a manufacturer representative (rep) and they were able to get the pp to communicate with the ins after they unplugged the antenna.They confirmed that the patient was able to turn their ins on.They were advised to get a replacement programmer antenna.No patient symptoms were reported.A replacement pp antenna 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
The replacement antenna did not resolve the issue.An email was sent to replace the patient programmer.
 
Manufacturer Narrative
Continuation of d10: product id 37092, serial# unknown, product type accessory.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.
 
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 Key11874416
MDR Text Key252346128
Report Number3004209178-2021-08238
Device Sequence Number1
Product Code PJS
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 other
Type of Report Initial,Followup,Followup,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/28/2019
Device Model Number37601
Device Catalogue Number37601
Was Device Available for Evaluation? No
Date Manufacturer Received05/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
"SEE H10...."; "SEE H10...."
Patient Age79 YR
Patient Weight68
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