Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SCREW-IN LEAD; ELECTRODE, PACEMAKER, PERMANENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MPRI SCREW-IN LEAD; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 5071-25
Medical Device Problem Code Failure to Capture (1081)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/01/2020
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 that the right ventricular (rv) lead exhibited no capture at high output and loss of capture.The rv lead was cut, capped and replaced.No patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SCREW-IN LEAD
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10725068
Report Number2649622-2020-20550
Device Sequence Number14316962
Product Code DTB
UDI-Device Identifier00643169638624
UDI-Public00643169638624
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
P120017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/23/2020
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 Date08/20/2022
Device Model Number5071-25
Device Catalogue Number5071-25
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2020
Initial Report FDA Received Date10/23/2020
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
W1SR01 IPG
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age21 MO
-
-