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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA S MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

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MPRI ATTAIN PERFORMA S MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P Back to Search Results
Model Number 459888
Device Problems Signal Artifact/Noise (1036); High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during left ventricular (lv) lead implant, there was high undefined impedance and severe noise on a specific pacing configuration.All other pacing configurations functioned appropriately.The lead was removed and a new lead was implanted.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.Analysis indicated the proximal conductor worn and not fractured in vi-vo.The analyst noted the proximal conductor failed continuity test within the connector due to missing crimp.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.Analysis indicated there was an issue with the lead connector.The analyst noted the proximal conductor failed continuity test within the connector due to missing crimp.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
ATTAIN PERFORMA S MRI SURESCAN
Type of Device
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key12728724
MDR Text Key279305960
Report Number2649622-2021-21723
Device Sequence Number1
Product Code OJX
UDI-Device Identifier00643169601871
UDI-Public00643169601871
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 04/16/2024
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 Lay User/Patient
Device Expiration Date05/12/2023
Device Model Number459888
Device Catalogue Number459888
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/11/2021
Initial Date FDA Received11/01/2021
Supplement Dates Manufacturer Received11/23/2021
03/05/2024
03/26/2024
Supplement Dates FDA Received12/01/2021
03/25/2024
04/16/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2021
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 Age69 YR
Patient SexMale
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