FDA MedWatch: Medtronic
voluntarily suspends distribution of its
Sprint Fidelis defibrillation leads because
a small number of fractures have been detected
MedWatch - The FDA Safety
Information and Adverse Event Reporting Program
October 16, 2007
FDA issued a statement announcing
Medtronic's decision to voluntarily suspend
distribution of its Sprint Fidelis defibrillation
leads because a small number of fractures have
been detected. As a result of Medtronic's action,
no more Sprint Fidelis leads will be sold or
manufactured and any remaining product should
be pulled from inventory and returned to the
company.
When a defibrillator lead
is slightly more prone to fracture, most
leads will function well, as is the case
with Sprint Fidelis. In the infrequent circumstance
where a lead actually breaks, or "fractures,"
the lead may send false signals that cause
inappropriate defibrillator shocks, or therapies
such as pacing or shocks may not be delivered.
Current adverse event information
indicates that fractures have occurred in less
than 1 percent of the approximately 268,000
of these leads implanted worldwide. Patients
who are implanted with this lead are encouraged
to contact their physicians for further information.
Read
the complete MedWatch 2007 Safety Summary including a link to the
FDA Statement and Consumer Questions and
Answers.
