MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY STEERABLE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 4554

Device Problems Pocket Stimulation (1463); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2018

Event Type  malfunction  

Event Description

It was reported that the patient presented to the clinic with phrenic nerve stimulation (pns) and a high capture threshold on the left ventricular (lv) lead.Diagnostic imaging confirmed that the lv lead was dislodged.The physician elected to reprogram the lv pacing configuration of the device to resolve the event.The patient was stable with no adverse consequences.

• Brand Name: ACUITY STEERABLE
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8275772
• MDR Text Key: 134061930
• Report Number: 2124215-2019-00103
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526419324
• UDI-Public: 00802526419324
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P050046/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2015
• Device Model Number: 4554
• Device Catalogue Number: 4554
• Device Lot Number: 193924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR