MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) RIATA ST ACTIVE FIXATION; DEFIBRILLATION LEAD

Model Number 7000/60

Device Problems Fracture (1260); Over-Sensing (1438); Retraction Problem (1536); Failure to Disconnect (2541)

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

Event Date 02/21/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2023-13522.It was reported that the patient presented for in-clinic for a routine device check.Upon interrogation alerts for non-sustained right ventricular over-sensing was observed.Further evaluation found that both the right ventricular (rv) and right atrial (ra) leads had exhibited over-sensed noise.High voltage therapy was disabled via programming.The patient was stable.

Event Description

New information received notes that both the right ventricular (rv) and right atrial (ra) lead and replaced.There were no patient consequences.

Manufacturer Narrative

Additional information: b5 the reported events were oversensing noise, lead fracture and helix mechanism issue.As received, a partial lead was returned in two pieces with helix found extended, bent and clogged with blood/tissue.The reported event of helix mechanism issue was confirmed.The helix mechanism/extension length test was unable to be performed due to the damaged, as received.The cause of the reported event of helix mechanism issue was due to the helix being stretched consistent with procedural damage.The reported event of oversensing noise was confirmed.Visual inspection of the lead found an external insulation abrasion breaching the outer insulation and exposing the ring electrode coil at the is-1 connector leg.The cause of the reported event was due to the exposure of the ring electrode coil in the abrasion zone consistent with friction to the device can.The reported event of lead fracture was not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.

Event Description

New information received notes that during the procedure there physician had difficulty retracting the helices of both the right ventricular (rv) and right atrial (ra) leads.Additionally, fracture of both the ra and rv leads was the suspected cause of lead noise.

Event Description

New information noted that the right ventricular and atrial leads adhered to each other and failed to disconnect.

• Brand Name: RIATA ST ACTIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16526899
• MDR Text Key: 311122483
• Report Number: 2017865-2023-13520
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2023

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: Health Professional
• Device Expiration Date: 06/30/2010
• Device Model Number: 7000/60
• Device Lot Number: 0002140654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 04/26/2023; 05/08/2023; 06/27/2023
• Supplement Dates FDA Received: 05/16/2023; 05/27/2023; 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2007
• 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
• Treatment: LEFT VENTRICULAR LEAD; UNIFY ASSURA
• Patient Outcome(s): Required Intervention
• Patient Sex: Female