This report is based solely on reviewed clinical data from the device.If additional relevant information is received, a supplemental report will be submitted.This device was included in that field action.Based on the information received and without the return of the product, it could not determine this device performed as described in the field action.This model number is not approved for distribution in the united states, however, it is similar to a device marketed in the u.S.The event is being reported due to an alleged malfunction.Concomitant products: 7122/65cm, implantable tachy lead.(b)(4).
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