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: MEDTRONIC, INC. PACING SYSTEM ANALYZER; PROGRAMMER, PACEMAKER
  • 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
 

MEDTRONIC, INC. PACING SYSTEM ANALYZER; PROGRAMMER, PACEMAKER Back to Search Results
Model Number R2290
Medical Device Problem Code Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product analysis: it was determined on analysis that the programmer analyzer tested out of specification electrically during functional tests as error codes, battery voltage and pacing operation were noted.The analyzer was scrapped.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The programmer analyzer which was returned for preventive maintenance subsequently tested out of specification during manufacturer¿s analysis.There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PACING SYSTEM ANALYZER
Common Device Name
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key12743183
Report Number2182208-2021-04316
Device Sequence Number19826804
Product Code KRG
UDI-Device Identifier00721902710322
UDI-Public00721902710322
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/03/2021
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 Other
Device Model NumberR2290
Device Catalogue NumberR2290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/19/2021
Initial Report FDA Received Date11/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-