MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC NANOSTIM LEADLESS PACEMAKER; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD

Catalog Number S1DLCP

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 03/10/2015

Event Type  Injury  

Event Description

A intra-ventricular pacemaker was to be placed in the patient.It was dislodged and advanced into the pulmonary artery.The doctor attempted to retrieve it and was unable to retrieve the device.It remained in the patient.Ir to attempt removal the following day.Patient was admitted to the icu and they were later able to successfully remove the device.

• Brand Name: NANOSTIM LEADLESS PACEMAKER
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; 15900 valley view ct.; sylmar CA 91342
• MDR Report Key: 4647578
• MDR Text Key: 5752968
• Report Number: 4647578
• Device Sequence Number: 1
• Product Code: DXY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: S1DLCP
• Device Lot Number: NEN141028A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR