Permanent Pacemaker Electrode

Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components

Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.

enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents

The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.

Medtronic, Sutureless, unipolar, myocardial, screw-in pacing lead, 5071-15, 5071-25, 5071-35 & 5071-53, Medtronic, Inc., Minneapolis, MN 55432, Manufactured in:

Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that specific package seals could be compromised. Medtronic is not aware of any patient injury due to this packaging issue and their evaluation indicated the risk of patient injury is remote. However, a compromised package seal could potentially affect product sterility.

Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane Nort

The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.

Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner package have been sterilized by ethylene-oxide gas. Manufactured by:

The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.

Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY2

The O-rings are over tolerance making it hard to connect the leads to the pacemaker.

Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and

Enpath Lead Adapters: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.

Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T Bipolar Endocardial Lead to an AngelMed Guardian IMD. Manufactured for Angel Medical Sy

The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.