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. PROGRAMMING HEAD; 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. PROGRAMMING HEAD; PROGRAMMER, PACEMAKER Back to Search Results
Model Number 2067L
Medical Device Problem Code Corroded (1131)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
It was determined on analysis that the radiofrequency(rf) head tested out of specification due to contamination / corrosion.Due to extensive repairs the rf head will be scrapped.A replacement rf head was provided.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the radiofrequency (rf) head which was returned as an associate device tested out of specification during manufacturers analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROGRAMMING HEAD
Common Device Name
PROGRAMMER, PACEMAKER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key11775825
Report Number2182208-2021-01820
Device Sequence Number14410708
Product Code KRG
UDI-Device Identifier00613994435125
UDI-Public00613994435125
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
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/05/2021
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 Number2067L
Device Catalogue Number2067L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/28/2021
Initial Report FDA Received Date05/05/2021
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
2090 PROGRAMMER, 229047 ANALYZER
-
-