Device product

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

Z-1480-2022

November 05, 2020

Class II

Product summary

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event: Event 90429
Status: Ongoing
Classification: Class II
Quantity: 3 units
Official record key: device-enforcement:Z-1480-2022

Official wording

Reason: Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.

Code information: GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S

Distribution pattern: US Nationwide distribution in the states of Indiana and CA.

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

Manufacturing error
Potency or specification failure
reason.potency_specification_failure · v1.0.0

out of specification