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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) PACEMAKER ELECTRODE

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MPRI ATTAIN PERFORMA STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 439888
Device Problems Electrical /Electronic Property Problem (1198); Low impedance (2285)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2019
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the left ventricular pacing lead was below the expected lower range.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that there was left ventricular (lv) lead warning with polarity change.There was also low impedance.It was also reported there was invalid data on the remote data.The device and lead remain in use.No 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) 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 Key8696379
MDR Text Key147913915
Report Number2649622-2019-10168
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 06/13/2019
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 05/20/2019
Initial Date FDA Received06/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2018
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
407658 LEAD, W4TR01 IPG, 407652 LEAD
Patient Age67 YR
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