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U.S. Department of Health and Human Services

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

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MPRI ATTAIN PERFORMA MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P Back to Search Results
Model Number 429878
Device Problems Device Contamination with Body Fluid (2317); Activation, Positioning or Separation Problem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2022
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 during the procedure, a competitor guidewire became stuck in the left ventricular (lv) lead which was caused by a backload of blood.It was not possible to withdraw the guidewire.The lead was removed and replaced.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 distal conductor of the lead was obstructed due to a guidewire stuck in the lumen.The guidewire was kinked/buckled.The tip seal on the distal electrode of the lead showed evidence of blood ingression.Visual analysis of the lead indicated damage at implant.The analyst noted the distal end of the lead obstructed by guidewire stuck in the distal tip nose.The blood ingress in lead from the tip seal.By design, left heart leads are manufactured with a septum in the tip that will sometimes allow blood ingress.No insulation breach was observed.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
ATTAIN PERFORMA 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 Key15008479
MDR Text Key304461991
Report Number2649622-2022-13687
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeLO
PMA/PMN Number
P080006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/03/2022
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 Date04/21/2024
Device Model Number429878
Device Catalogue Number429878
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/11/2022
Initial Date FDA Received07/13/2022
Supplement Dates Manufacturer Received08/01/2022
Supplement Dates FDA Received08/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/26/2022
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 Age54 YR
Patient SexMale
Patient Weight95 KG
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