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U.S. Department of Health and Human Services

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

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MPRI ATTAIN PERFORMA STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P Back to Search Results
Model Number 439888
Device Problems Capturing Problem (2891); Unstable Capture Threshold (3269)
Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194)
Event Date 05/08/2022
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: dtma1q1 crt-d implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced low blood pressure and dizziness.The left ventricular (lv) lead exhibited an increasing and widely varying threshold.The lv lead remains in use. no further patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN PERFORMA 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
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 Key14517029
MDR Text Key292794694
Report Number2649622-2022-10225
Device Sequence Number1
Product Code OJX
UDI-Device Identifier00643169601857
UDI-Public00643169601857
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
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/26/2022
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 Lay User/Patient
Device Expiration Date11/05/2020
Device Model Number439888
Device Catalogue Number439888
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/08/2022
Initial Date FDA Received05/26/2022
Date Device Manufactured12/10/2018
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
0184 LEAD, 4472 LEAD
Patient Age83 YR
Patient SexMale
Patient Weight89 KG
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