inforMED
OtherGZE

MEDTRONIC PHRENIC NERVE PAD

Received May 15, 2002 · Event occurred Apr 22, 2002

Report 394944 · MDR key 394944

Device

Generic name

Phrenic Nerve Pad

Manufacturer

Medtronic Usa, Inc

Model number

UNK

Catalog number

UNK

Lot number

UNK

Product problems

  • Device, or device fragments remain in patient
  • Use of Device Problem

Patient

60 YR

  • Bleeding
  • Nonresorbable materials, unretrieved in body
  • Surgical procedure, additional

Narrative

Description of Event or Problem

PT UNDERWENT AORTIC VALVE REPLACEMENT AND SINGLE VESSEL CORONARY ARTERY BYPASS. POST OPERATIVELY PT RETURNED TO SURGERY FOR RE-EXPLORATION OF MEDIASTINAL BLEEDING. PT CODED NINE DAYS LATER AND EXPIRED. PT ALSO HAD TIA THE DAY BEFORE. DURING AUTOPSY ON 05/2002, A PHRENIC NERVE PAD WAS NOTED TO BE RETAINED IN THE PERICARDIAL SPACE ADJACENT TO THE HEART.