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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN PERFORMA MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

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MEDTRONIC, INC. ATTAIN PERFORMA MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P Back to Search Results
Model Number 429888
Device Problems Failure to Capture (1081); Capturing Problem (2891); Device Dislodged or Dislocated (2923)
Patient Problems Low Blood Pressure/ Hypotension (1914); Undesired Nerve Stimulation (1980); Transient Ischemic Attack (2109); Perforation of Vessels (2135)
Event Date 01/01/2022
Event Type  Injury  
Event Description
Literature was reviewed regarding ventricular pacing.The authors described one patient who received inappropriate therapy due to oversensing on the right ventricular (rv) lead, another patient experienced a middle cardiac vein perforation, one patient who required inotropic support during the implant procedure due to hypotension, one patient who had a transient ischemic attack (tia) two days post procedure, and patients with phrenic nerve stimulation.There were leads which exhibited dislodgements, loss of capture, and increased thresholds.Leads were revised or repositioned.The status of the leads is unknown.No additional adverse patient effects or product performance issues were reported.
 
Manufacturer Narrative
This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline gender/age characteristics is male/59 years old.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: therapeutic benefits of distal ventricular pacing in mid-cavity obstructive hypertrophic cardiomyopathy.Therapeutic advances in cardiovascular disease.2022, vol.16: 1¿12.Pmid: 35916371 doi: 10.1177/17539447221108816.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)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key16685946
MDR Text Key312757357
Report Number2182208-2023-00934
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P080006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Physician
Type of Report Initial
Report Date 04/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number429888
Device Catalogue Number429888
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/27/2023
Initial Date FDA Received04/05/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNKNOWN COMPETITOR ICD AND LEADS.
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age59 YR
Patient SexMale
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