It was reported that the patient underwent esophageal surgery, bradycardia before surgery.It was stated that a temporary pacemaker was to be inserted, during the implantation process, the temporary pacing electrode catheter was not tightly connected, and there was no pacing signal, resulting in inability to use.It was noted that the electrode connection was loose and the connection was not tight.
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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