During the use of some TB – Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. In the last six years, a total of four serious injuries were reported to Oscor which were attributed to a connector cap malfunction causing the lead connector to separate during use potentially leading to an interruption of the pacing system. No deaths were reported; however the risk for possible injury is a concern if the connectors separates during use.
|TB Specification Description|
|Series||French size||Pin||Curve Type|
Table 1: TB-Temporary Bipolar Pacing Lead with Un-shrouded Pins Affected Models.
For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Continuous monitoring is required.
Customer may contact Oscor’s Customer Relations Group, Monday to Friday from 8:30AM to 5:30PM Eastern Time at 727-937-2511 or via email at TB@oscor.com.
Healthcare professionals are encouraged to report any malfunction and/or adverse events related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.