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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA S MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

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MPRI ATTAIN PERFORMA S MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 459878
Device Problems Electrical /Electronic Property Problem (1198); High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Muscle Stimulation (1412)
Event Date 05/05/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that there an alert for out of range, high left ventricular (lv) lead impedance, which led to a polarity switch to a unipolar configuration.It was noted the patient experienced extracardiac stimulation in the unipolar configuration.The lv lead was reprogrammed and remains in use.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information reported the lv lead was programmed off.
 
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Brand Name
ATTAIN PERFORMA S 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 Key8680654
MDR Text Key147389426
Report Number2649622-2019-09835
Device Sequence Number1
Product Code OJX
UDI-Device Identifier00643169601864
UDI-Public00643169601864
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/15/2019
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 Date04/18/2020
Device Model Number459878
Device Catalogue Number459878
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/14/2019
Initial Date FDA Received06/07/2019
Supplement Dates Manufacturer Received06/10/2019
08/09/2019
Supplement Dates FDA Received06/12/2019
08/15/2019
Date Device Manufactured05/10/2018
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
W4TR01 CRTD, 5076-52 LEAD, 5076-58 LEAD
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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