MAUDE Adverse Event Report: BIOTRONIK PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number S60

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problem Cardiac Arrest (1762)

Event Type  Injury  

Event Description

A call to technical services was made on (b)(6) 2013, stating that during a check for post biv upgrade.There was no capture for lv tip to device and 5 at 2 tip to rv.As per email received from representative on (b)(6) 2013, this lead was dislodged and was repositioned.There was asystole greater than 2 seconds.The physician was dr.(b)(6) at (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17534839
• MDR Text Key: 321150879
• Report Number: MW5141738
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: S60
• Patient Sequence Number: 1