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 SUBQ; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
  • 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 SUBQ; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 6996SQ58
Medical Device Problem Codes Fracture (1260); High impedance (1291); Impedance Problem (2950)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/02/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Continuation of concomitant products: 694765 lead, implanted (b)(6) 2011; dtbb1d1 crt-d, implanted (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the subcutaneous lead exhibited varying, high, and undefined impedance intermittently due to a fracture.The lead was explanted and replaced.It was also reported the right ventricular (rv) lead exhibited high threshold.Follow up yielded no information.The rv lead remains in use.No patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUBQ
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key7415657
Report Number2649622-2018-04008
Device Sequence Number13654727
Product Code LWS
UDI-Device Identifier00613994568021
UDI-Public00613994568021
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 04/10/2018
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 Date08/06/2018
Device Model Number6996SQ58
Device Catalogue Number6996SQ58
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/02/2018
Initial Report FDA Received Date04/10/2018
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 Hospitalization; Required Intervention;
Patient Age65 YR
-
-