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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN ABILITY PLUS; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
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MPRI ATTAIN ABILITY PLUS; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 429678
Medical Device Problem Codes Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/07/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that loss of left ventricular (lv) lead capture was noted during a follow-up check and it was noted the lv lead had dislodged and pulled back into the coronary sinus (cs).The lv lead would not capture at max output and exhibited a high pacing threshold.The lv lead was repositioned into a branch of the cs and remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN ABILITY PLUS
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 Key7092084
Report Number2649622-2017-13994
Device Sequence Number1379357
Product Code OJX
UDI-Device Identifier00643169860124
UDI-Public00643169860124
Combination Product (Y/N)N
Initial Reporter StateNM
Initial Reporter CountryUS
PMA/510(K) Number
P080006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/06/2017
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
Operator of Device Lay User/Patient
Device Expiration Date03/01/2019
Device Model Number429678
Device Catalogue Number429678
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/07/2017
Initial Report FDA Received Date12/07/2017
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
(B)(4) LEAD, (B)(4) LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age87 YR
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