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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) PACEMAKER ELECTRODE

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MPRI ATTAIN STABILITY QUAD MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 479878
Device Problem Failure to Capture (1081)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2020
Event Type  Injury  
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 was unable to capture at high outputs.The lead was capped and replaced with epi cardial leads.No patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN STABILITY QUAD MRI SURESCAN
Type of Device
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
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 Key10816842
MDR Text Key215515218
Report Number2649622-2020-21833
Device Sequence Number1
Product Code OJX
UDI-Device Identifier00643169860414
UDI-Public00643169860414
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/10/2020
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 Expiration Date04/01/2021
Device Model Number479878
Device Catalogue Number479878
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/10/2020
Date Device Manufactured04/22/2019
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
DTMA1QQ CRTD, 407652 LEAD, 6935M62 LEAD
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age80 YR
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