MAUDE Adverse Event Report: BIOTRONIK. INC. SOLIA PACEMAKER LEAD WIRE; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 377179

Device Problems Positioning Failure (1158); Entrapment of Device (1212); Deformation Due to Compressive Stress (2889)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/23/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 patient presented to ep lab (electrophysiology lab) for placement of a dual chamber pacemaker, during ventricular lead placement, repositioning of the lead was required however the lead was not able to be removed from its attachment site due to distortion of the deployment screw.Decision was made to cap the lead, close chest wound, and patient returned to nursing unit for continued care and monitoring.Fda safety report id #(b)(4).

• Brand Name: SOLIA PACEMAKER LEAD WIRE
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): BIOTRONIK. INC.
• MDR Report Key: 15310987
• MDR Text Key: 298954432
• Report Number: MW5111747
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 377179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White