inforMED
OtherDKY

PHILIS SR

Received Apr 13, 2005

Report 1028232-2005-00030 · MDR key 592933

Device

Generic name

Pacemaker

Model number

331 446

Catalog number

SEE MODEL NUMBER

Lot number

NA

Product problems

  • Explanted

Patient

UNKNOWN

  • Death
  • Surgical procedure
  • Hospitalization required

Narrative

Description of Event or Problem

DEVICE RETURNED WITH INCOMPLETE OOS AND NO CLINICAL DATA. INCOMPLETE OOS INDICATES PATIENT EXPIRED.