KFJClass IIIImplant
Materials, Repair Or Replacement, Pacemaker
Cardiovascular · 21 CFR 870.3710
MDR events10All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances3All time
Recent MDR events
10 adverse event reports on file
- LEAD SERVICE KITAug 12, 2023MalfunctionMedtronicMW5132740
- UNKNOWNAug 12, 2023MalfunctionSorinMW5138469
- LEAD SERVICE KITApr 10, 2012MalfunctionMedtronic, Inc.2182208-2012-01170
- NONEDec 12, 2011InjuryMedtronic, Inc.2182208-2011-02995
- NONEOct 13, 2011MalfunctionMedtronic, Inc.2182208-2011-02210
- NONEOct 13, 2011MalfunctionMedtronic, Inc.2182208-2011-02211
- NONEOct 13, 2011MalfunctionMedtronic, Inc.2182208-2011-02212
- NONEOct 13, 2011MalfunctionMedtronic, Inc.2182208-2011-02213
- NONEOct 13, 2011MalfunctionMedtronic, Inc.2182208-2011-02214
- NONEDec 14, 2010InjuryMedtronic, Inc.2182208-2010-01013
Event type breakdown
Malfunction8
Injury2
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Break6
Mechanical Problem5
Adverse Event Without Identified Device or Use Problem1
Device Difficult to Setup or Prepare1
Insufficient Device Problem Information1
Loose or Intermittent Connection1
Trend for “Break”
No history to chart.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.