Description of Event or Problem · 1
ON OCTOBER 22, 1992, A PATIENT-MALE RECEIVED A MEDTRONIC ACTIVITREX PACEMAKER IMPLNTED BY A CARDIOVASCULAR SURGEON. THIS PACEMAKER WAS IMPLANTED, AS WAS EXPECTED, WITH THE USUAL LEAD OF A SINGLE VENTRICULAR PASSIVE FIXTURE TIMED LEAD IN THE RIGHT VENTRICLE. DURING IMPLANTATION THE REPORTED LEAD IMPEDENCE WAS 1429 OHMS BIPOLAR AND 1450 OHMS UNIPOLAR. SUBSEQUENTLY WITH A 24 HOUR PERIOD, THE ARRHYTHMIA SERVICE IDENTIFIED AN IMPEDANCE OF 1859 OHMS IN THE BIPOLAR MODE, AND ON REPEAT 1750 OHMS BIPOLAR AND 1652 OHMS UNIPOLAR. A CALLED WAS PLACED TO THE MANUFACTURER REPRESENTATIVE WHO NOTED THAT EIGHT SUCH DEFECTIVE LEADS HAVE BEEN NOTED BY THE COMPANY AND THEIR RECOMMENDATION WAS TO RE-IMPLANT ANOTHER LEADINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.