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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI LEAD END CAP KIT; ADAPTOR, LEAD, PACEMAKER
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MPRI LEAD END CAP KIT; ADAPTOR, LEAD, PACEMAKER Back to Search Results
Model Number 5867-3M
Medical Device Problem Codes Capturing Problem (2891); Impedance Problem (2950)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/09/2020
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 during use of the right atrial (ra) lead remote transmission revealed a trend for atrial thresholds and impedance increase.The ra lead remains in use.The patient will be monitored in clinic and remote transmissions.No patient complications have been reported as a result of this event.
 
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Brand Name
LEAD END CAP KIT
Common Device Name
ADAPTOR, LEAD, PACEMAKER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10329294
Report Number2649622-2020-14336
Device Sequence Number19726513
Product Code DTD
UDI-Device Identifier00613994500298
UDI-Public00613994500298
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K911048
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/27/2020
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 Date09/26/2020
Device Model Number5867-3M
Device Catalogue Number5867-3M
Device Lot NumberVA1AYHZ
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/09/2020
Initial Report FDA Received Date07/27/2020
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
429888 LEAD, 6935M62 LEAD, DTMA2QQ CRT-D
Patient Age85 YR
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