MAUDE Adverse Event Report: ST. JUDE MEDICAL RV LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 7121

Device Problems High impedance (1291); Protective Measures Problem (3015)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

Jpd updated on 9-may-2023 at 2:00pm et: caller called back asking what alert should they turn off to prevent nuisance alerts for the rv bipolar impedance out of range alert? instructed the caller how to turn off the rv pacing out of range impedance alert, and explained that they'll now rely on the rv lia alert to notify them of any potential future issues with the rvtip/rvcoil (rvpace/sense portion of the lead).Caller stated that the rv lia alert was on in the patient's device.D: caller provided patient serial number.R: looked up patient in carelink.Confirmed: 05-may-2023 03:00:09 *rv bipolar lead impedance >3000 ohms.Reviewed lead trends with isolated impedance spike on bipolar (ttr) trend.Ttc trend stable, device currently programmed ttc for p/s recommended viewing rvt-rvr and rvt-rvc egms simultaneously, while performing provocative movements, isometrics, and pocket manipulation.If non-physiologic noise is seen on both channels, this indicates that there is an issue with rvt electrode.If noise is seen only on ttr this indicates there is an issue with rvr electrode.If noise is only seen on ttc egm this indicates an issue with rvc electrode.Discussed lead anatomy: tip vs.Coil vs.Ring additionally, since lead is abbott/sjm durata, transferred caller to abbott/sjm technical services for further troubleshooting specific to the rv lead.Dependency: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17488250
• MDR Text Key: 320698493
• Report Number: MW5120951
• Device Sequence Number: 1
• Product Code: NVY
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 7121
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1