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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN ABILITY STRAIGHT; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
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MPRI ATTAIN ABILITY STRAIGHT; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 439688
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Necrosis (1971)
Date of Event 12/17/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported the cardiac resynchronization therapy defibrillator (crt-d) system was explanted approximately six weeks post implant due to pocket necrosis.It was further reported that prior to device system implant the patient had received radiation to their upper chest.No further patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN ABILITY STRAIGHT
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 Key8237850
Report Number2649622-2019-00654
Device Sequence Number16208980
Product Code OJX
UDI-Device Identifier00643169601819
UDI-Public00643169601819
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
P080006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/10/2019
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? No
Operator of Device Lay User/Patient
Device Expiration Date11/07/2018
Device Model Number439688
Device Catalogue Number439688
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/17/2018
Initial Report FDA Received Date01/10/2019
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
DTMB1D4 CRTD, 407688 LEAD, 6947M55 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age63 YR
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