UNKNOWN
Received Jan 14, 2013 · Event occurred Dec 13, 2012
Report 2124215-2012-16851 · MDR key 2913199
Device
Product problems
- High impedance
- Connection Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
INFORMATION WAS RECEIVED THAT DURING THE PROCEDURE, THE SUTURE WAS NOT CONNECTED TO THE MUSCLE TISSUE. THE DEVICE HAD MOVED DOWNWARD TO THE LOWER PART OF THE ABDOMEN. THE CONNECTIONS WERE TIGHT THROUGH THIS AND ALL THREE ADAPTERS HAD INSULATION DAMAGE WHERE THE HEADER ENDS. IT WAS SUSPECTED THAT THE CHANGE OF DEVICE POSITION CREATED TOO MUCH TENSION ON THE ADAPTERS. AS NO DEVICE MALFUNCTION WAS SUSPECTED AND THERE WAS SUFFICIENT LONGEVITY, THE DEVICE REMAINS IMPLANTED WITH A NEW RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.
Additional Manufacturer Narrative
THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE WAS PROGRAMMED TO MONITOR ONLY AS THERE WERE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD. A CONNECTION ISSUE BETWEEN THE ADAPTER AND LEAD WAS SUSPECTED. AS A RESULT, A REVISION PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.