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U.S. Department of Health and Human Services

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

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MPRI ATTAIN PERFORMA; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 439888
Device Problems Failure to Capture (1081); Pacing Problem (1439)
Patient Problem Non specific EKG/ECG Changes (1817)
Event Date 01/26/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the right ventricular (rv) lead and left ventricular (lv) lead had loss of capture noted on hospital telemetry strips during routine pacing.Capture was regained when the healthcare professionals repositioned the patient, who was asleep at the time of the loss of capture, which resulted in pauses.It was noted that the rv lead had unstable threshold measurements.Reprogramming was done, and the both leads remain in use.No further patient complications have been reported as a result of this event.
 
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 was performed, and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ATTAIN PERFORMA
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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8362200
MDR Text Key136880604
Report Number2649622-2019-02950
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 company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/25/2019
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? Yes
Device Operator Lay User/Patient
Device Expiration Date09/17/2020
Device Model Number439888
Device Catalogue Number439888
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2019
Initial Date FDA Received02/22/2019
Supplement Dates Manufacturer Received02/22/2019
Supplement Dates FDA Received02/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2018
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
W4TR01 IPG, 407658 LEAD, 407652 LEAD
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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