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U.S. Department of Health and Human Services

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

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MPRI ATTAIN STABILITY QUAD MRI SURESCAN DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P Back to Search Results
Model Number 479888
Device Problem Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the left ventricular (lv) lead triggered an audible alert. Review of a remote transmission showed that the lv lead triggered an alert for low left ventricular (lv) lead impedance. No patient complications have been reported as a result of this event. No patient complications have been reported as a result of this event.
 
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Brand NameATTAIN STABILITY QUAD MRI SURESCAN
Type of DeviceDRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud PR 1131
SZ 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key13841265
MDR Text Key287598815
Report Number2649622-2022-05283
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/29/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number479888
Device Catalogue Number479888
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/21/2022 Patient Sequence Number: 1
Treatment
W4TR02 CRT-P, 5076-52 LEAD, 5076-58 LEAD
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