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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN STARFIX; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
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MPRI ATTAIN STARFIX; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 419588
Medical Device Problem Code Low impedance (2285)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/31/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the right atrial (ra) lead was undersensing during recorded arrhythmia episodes.The left ventricular (lv) lead had triggered a warning for out-of-range pacing impedance which was currently noted to be low.The leads remain in use.No patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN STARFIX
Common Device Name
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key8271418
Report Number2649622-2019-01220
Device Sequence Number16632382
Product Code OJX
UDI-Device Identifier00643169590649
UDI-Public00643169590649
Combination Product (Y/N)N
Initial Reporter StateSD
Initial Reporter CountryUS
PMA/510(K) Number
P060039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 01/23/2019
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
Operator of Device Lay User/Patient
Device Expiration Date06/10/2018
Device Model Number419588
Device Catalogue Number419588
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/31/2018
Initial Report FDA Received Date01/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
C6TR01, CRT-P, 5076-52, LEAD, 5076-45, LEAD.
Patient Age84 YR
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