Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Visual examination identified a hole in the (rv) setscrew seal plug.Next, the pacing, and sensing functions of the device were verified to be operating normally.Review of evidence submitted by the field indicated that the noise on the ventricular channel was consistent with temporary body fluid infiltration through the seal plug, coupled with air escaping the seal plug.Setscrew seal plugs are designed to permit setscrew wrench insertion yet prevent body fluids from entering the header cavities.If an accessory sensing pathway is present due to fluid intrusion, there is a potential for oversensing and, thus, inhibition of pacing or delivery of inappropriate therapy.
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