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U.S. Department of Health and Human Services

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

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MPRI ATTAIN PERFORMA MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 429878
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: acticor 7 crtd, implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the left ventricular (lv) lead had noise with oversensing.Reprogramming was done and the lead remains in use.The patient is a participant in a clinical study.No patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN PERFORMA 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 Key11812742
MDR Text Key250218514
Report Number2649622-2021-09543
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P080006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 05/12/2021
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 Date01/21/2018
Device Model Number429878
Device Catalogue Number429878
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/10/2021
Initial Date FDA Received05/12/2021
Date Device Manufactured02/04/2016
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
DTMB2QQ CRTD, 5076 LEAD, 6935M
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight88
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