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U.S. Department of Health and Human Services

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

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MPRI ATTAIN ABILITY STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P Back to Search Results
Model Number 439688
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
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 the implant procedure, after the left ventricular (lv) lead was fixed and measurements were obtained with the analyzer, a lot of noise was observed.The connections were changed several times, but the noise persisted.The lead was not used, and another 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, analyzed and no anomalies were found.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 ABILITY STRAIGHT MRI SURESCAN
Type of Device
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key12049806
MDR Text Key257770968
Report Number2649622-2021-12687
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
PMA/PMN Number
P080006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/19/2021
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 Date02/10/2022
Device Model Number439688
Device Catalogue Number439688
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2021
Initial Date Manufacturer Received 06/18/2021
Initial Date FDA Received06/23/2021
Supplement Dates Manufacturer Received07/23/2021
Supplement Dates FDA Received08/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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