Customer Communications
Potential Loss Of Device Hermeticity

Potential Loss Of Device Hermeticity

ConsultaŽ CRT-P and SyncraŽ CRT-P
Original Date of Communication: June 2013

View specific models that this applies to

Product

Consulta® CRT-P and Syncra® CRT-P. You may use the "Search for Information by Serial Number" tool on the home page of this web site to determine if a specific device is affected.

Advisory

Medtronic has identified an issue with a connector bracket weld on a subset of Consulta CRT-P models and Syncra CRT-P devices manufactured between April 1 and May 13, 2013.  This type of connector bracket weld is unique to Consulta and Syncra CRT-P devices and no other Medtronic device models are affected. 

An out-of-specification weld could result in a loss of device hermeticity and compromised device functionality. There have been no reported or confirmed device failures or patient injuries.  Medtronic estimates the rate of out-of-specification welds to be 1-2% in this subset of devices. 

Non-implanted devices from this subset have been recalled to Medtronic for re-inspection with additional controls to ensure that the weld meets specification. In June 2013, Medtronic communicated to impacted physicians that up to 779 devices worldwide (43 in the U.S.) may have been implanted from this subset. The Physician Letter is available at http://www.medtronic.com/for-healthcare-professionals/consulta-syncracrt-p/index.htm  

Patient Management Recommendations (As of June 2013)

As a result of on-going investigation and consultation with Medtronic’s Independent Physician Quality Panel, Medtronic offers the following patient management recommendations:

  • Physicians should advise their patients to seek medical attention immediately if they experience a return of symptoms related to bradycardia or heart failure.
  • If considering prophylactic device replacement for pacemaker-dependent patients with a device in the identified subset, physicians should carefully assess individual patient circumstances against the known risk of a device replacement.
  • Physicians should continue routine follow up in accordance with standard practice

Status Update

As of September 27, 2016, there have been no reported or confirmed device failures or patient injuries.


Initial Affected Population Number of Confirmed Advisory Related Events Estimated Remaining Active Population Current Malfunction Rate (confirmed malfunctions over total population)
Up to 779 Worldwide (44 United States) 0 Worldwide (0 United States) 170 Worldwide (33 United States) 0% Worldwide (0% United States)

 

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Specific Models This Applies To

www.medtronic.com/productperformance 951051