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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 479888
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/22/2020
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 replacement procedure, the left ventricular (lv) lead had high capture threshold and high impedance measurements.It was noted that during initial manipulation of the lead the impedance measurements were normal, but after ten minutes of manipulation the impedance turned into high measurements, the capture thresholds was high and there was noise on the electrograms (egm).The lead was not used, and another lead was implanted.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 Key10635626
MDR Text Key210010244
Report Number2649622-2020-19254
Device Sequence Number1
Product Code OJX
UDI-Device Identifier00643169860421
UDI-Public00643169860421
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 10/06/2020
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 Date05/12/2022
Device Model Number479888
Device Catalogue Number479888
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/22/2020
Initial Date FDA Received10/06/2020
Date Device Manufactured06/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age77 YR
Patient Weight123
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