MAUDE Adverse Event Report: ABBOTT HIGH VOLTAGE RV LEAD; DEFIBRILLATION LEAD

Model Number 7122/65

Device Problems Low Sensing Threshold (2575); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.Further information was requested but not received.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an implant procedure, low sensing threshold was noted on the right ventricular (rv) lead.A new rv lead was used to resolve the event.The patient was stable with no consequences.

Event Description

Additional information received indicating that there was no first replacement rv lead during the revision that was observed to have had low sensing.The low sensing threshold was observed on the rv channel on the lead reported in (b)(4) with a manufacturer report number of 2017865-2021-02431.

Manufacturer Narrative

Upon the receipt of additional information, the device should not have been submitted as a medical device report (mdr) as the product involved in this event has been reported in (b)(4) with a manufacturer report number of 2017865-2021-02431.

• Brand Name: HIGH VOLTAGE RV LEAD
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11201593
• MDR Text Key: 227761315
• Report Number: 2017865-2021-02149
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502153
• UDI-Public: 05414734502153
• Combination Product (y/n): N
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7122/65
• Device Catalogue Number: 7122-65
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1