Tester, Pacemaker Electrode Function
Cardiovascular · 21 CFR 870.3720
Recent MDR events
9 adverse event reports on file
- TESTER, PACEMAKER ELECTRODE FUNCTIONAug 12, 2023MalfunctionBiotronikMW5141865
- ERA 3000 DE/ENJul 14, 2015MalfunctionBiotronik Se & Co. Kg1028232-2015-02515
- ANALYZER / MERLIN PROGRAMMERNov 18, 2013MalfunctionSt. JudeMW5032963
- LINOX SMART SD 65/16Feb 5, 2013InjuryBiotronik Se & Co. Kg1028232-2013-00172
- KENTROX SL 65/16 STEROIDNov 12, 2010MalfunctionBiotronik Se & Co. Kg1028232-2010-02364
- *Jun 23, 2005Death*MW1035876
- EP3 STIMULATOR W/BATTERYSep 19, 2003Malfunction2247064-2003-00001
- EP MED SYSTEMSep 8, 2003InjuryEp Med System482168
- MEDTRONIC UNIPOLAR CONNECTORJul 29, 1994InjuryMedtronic, Inc.18099
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Remington Medical Inc.TerminatedNov 3, 2005
Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Inc
The vector selector has an electrical design flaw which prevents RV pacing.
Z-0124-06 · View FDA record ↗ - Medtronic Inc. Cardiac Rhythm ManagmentTerminatedNov 17, 2004
Medtronic CapSureFix Novus Lead Model 5076.
A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length.
Z-0207-05 · View FDA record ↗
Registered firms
12 firms currently registered for this product code
Abbott Medical
Sylmar, CA, US
Osypka Medical Gmbh
BERLIN, DE
Medtronic, Inc.
Mounds View, MN, US
Biotronik Se & Co. Kg
BERLIN, DE
Steris Corporation De Republica Dominicana, S.r.l.
Santo Domingo, DO
Technical Services For Electronics, Inc.
Jackson, MN, US
Remington Medical, S.a.
Santo Domingo Este, DO
Remington Medical, Inc.
ALPHARETTA, GA, US
Biotronik, Inc.
LAKE OSWEGO, OR, US
Isomedix Operations Inc.
SPARTANBURG, SC, US
510(k) clearances
10 clearances for this product code
- Medtronic, Inc.Feb 28, 2017
K163008 · CareLink SmartSync Device Manager - Pacing System Analyzer
- St Jude Medical, CrmdDec 21, 2010
K101982 · MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
- Biotronik, Inc.Dec 20, 2007
K073230 · MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS
- Remington Medical, Inc.May 19, 2005
K050884 · ADAPTER CABLE
- Biotronik, Inc.Dec 8, 2003
K033613 · MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- Biotronik, Inc.Jan 27, 2003
K022360 · ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.
- Ep Medical, Inc.Oct 21, 1993
K933069 · MODEL EP-2 CLINICAL STIMULATOR
- Siemens Corp.Dec 2, 1981
K812104 · SIEMENS-ELEMA PSA 376