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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN OVER THE WIRE LEAD; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
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MPRI ATTAIN OVER THE WIRE LEAD; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE Back to Search Results
Model Number 419378
Medical Device Problem Codes High impedance (1291); Impedance Problem (2950); High Capture Threshold (3266)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/25/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dtba1d1 crt-d, implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the left ventricular (lv) lead exhibited high and increasing pacing impedance, along with a high pacing threshold.The lv lead was reprogrammed and it was noted the lead would likely be revised at the time of the next device replacement.The lv lead remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN OVER THE WIRE LEAD
Common Device Name
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key8995794
Report Number2649622-2019-16445
Device Sequence Number19512353
Product Code LWP
UDI-Device Identifier00885074200729
UDI-Public00885074200729
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P010015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/11/2019
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
Operator of Device Lay User/Patient
Device Expiration Date03/07/2009
Device Model Number419378
Device Catalogue Number419378
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/25/2019
Initial Report FDA Received Date09/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age54 YR
Patient Weight77
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