The specimen is received with no fixative in a single container labeled with the patient's name and medical record number. It is designated on the requisition as "Removed pacemaker battery.” Received fresh is a medical device consistent with the Implantable Pulse Generator. There is a [ ] g, [4.5 x 4.5 x 0.8] cm grey, irregularly-shaped metal medical device with an attached transparent plastic port for wires. Inscribed is the name "Medtronic Adapta™" and the numbers "ADDR01", "DDDR", and “SN DE-IDENTIFIED", “USA." No tissue fragments are attached to the specimen or left in the container. Gross photographs are taken. The specimen is submitted for gross examination only.
(Grossed by [Prosector’s Name])
Note: It is important to dictate in the gross description and get a photograph of a readable brand name and serial number to identify the medical device or surgical hardware.
All foreign material removed from humans, whether of medical origin or not, is generally sent to pathology for gross examination only and documentation (except for temporary medical devices such as intravenous catheters). Some of these specimens will be of legal significance (e.g., silicone implants or bullets) and others will be subject to legislation that requires the tracing of certain medical devices.
The Safe Medical Devices Act (SMDA) went into effect in August 1993. This act requires that certain medical devices used after this date must be tracked by the manufacturer as well as by physicians and hospitals. Current information about implants can be found on the U.S. Food & Drug Administration website.5
The types of devices tracked include those with the following features:
- If the device is likely to have serious adverse health consequences should it fail.
- If the device is intended to be implanted in the human body for more than one year.
- If the device is intended to be life-sustaining or life-supporting.
