MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II EZ STEROX; IMPLANTABLE LEAD

Model Number 4471

Device Problems Signal Artifact/Noise (1036); Fracture (1260); Failure to Read Input Signal (1581); Low impedance (2285); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2024

Event Type  Injury  

Event Description

It was reported that there were concerns that this right ventricular (rv) lead was fractured or dislodged.Additionally, there were erratic intrinsic amplitudes on this channel.The right ventricular autothreshold (rvat) test was suspended as a result of low amplitudes.It was noted that there were noisy signals exhibited on the rv channel and on the evoked response channel on the right atrial autothreshold (raat) test.The impedance also has slightly decreased.The impedance remains within range.Technical services (ts) suggested further evaluation of both right atrial (ra) and rv leads and a chest x-ray.The lead remains in use.No adverse patient effects were reported.

Event Description

It was reported that there were concerns that this right ventricular (rv) lead was fractured or dislodged.Additionally, there were erratic intrinsic amplitudes on this channel.The right ventricular autothreshold (rvat) test was suspended as a result of low amplitudes.It was noted that there were noisy signals exhibited on the rv channel and on the evoked response channel on the right atrial autothreshold (raat) test.The impedance also has slightly decreased.The impedance remains within range.Technical services (ts) suggested further evaluation of both right atrial (ra) and rv leads and a chest x-ray.The lead remains in use.No adverse patient effects were reported.Subsequently, this lead was explanted and replaced for a left bundle branch (lbb) lead.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the lead was performed.Inspection of the lead body and electrode tip found no anomalies.Laboratory testing did not identify any lead characteristics that would have resulted in the clinical observation of dislodgement.No lead issues were noted that would have made dislodgement more likely than what is described in the instructions for use as a known inherent risk of the use of this product.

Event Description

It was reported that there were concerns that this right ventricular (rv) lead was fractured or dislodged.Additionally, there were erratic intrinsic amplitudes on this channel.The right ventricular autothreshold (rvat) test was suspended as a result of low amplitudes.It was noted that there were noisy signals exhibited on the rv channel and on the evoked response channel on the right atrial autothreshold (raat) test.The impedance also has slightly decreased.The impedance remains within range.Technical services (ts) suggested further evaluation of both right atrial (ra) and rv leads and a chest x-ray.The lead remains in use.No adverse patient effects were reported.Subsequently, this lead was explanted and replaced for a left bundle branch (lbb) lead.No additional adverse patient effects were reported.The lead was returned for analysis.

• Brand Name: FINELINE II EZ STEROX
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112-5798 ; 6515826168
• MDR Report Key: 19082424
• MDR Text Key: 339898002
• Report Number: 2124215-2024-21931
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960004/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2024

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: Lay User/Patient
• Device Model Number: 4471
• Device Catalogue Number: 4471
• Device Lot Number: 601249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 05/29/2024
• Supplement Dates FDA Received: 04/16/2024; 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2024
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male