MAUDE Adverse Event Report: ABBOTT CRM QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with the investigation results will be provided in the final report.  .

Event Description

During follow-up, phrenic nerve stimulation (pns) and inappropriate therapy were noted and attributed to the right ventricular (rv) lead.During an unrelated device exchange procedure, dislodgement of the left ventricular (lv) lead was noted instead to be the cause of the pns and inappropriate therapy.The lv lead was explanted.The patient expired due to procedural complications unrelated to the lv lead.

Manufacturer Narrative

The connector portion of the lead was returned.Electrical testing did not find any indication of conductor fractures or internal shorts.The s-curve height was unable to be measured as the distal portion of the lead was not received for analysis.Visual and x-ray inspections of the partial lead did not find any anomalies except for procedural damage.The reported events were not confirmed.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT CRM; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT CRM; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8826478
• MDR Text Key: 152192952
• Report Number: 2017865-2019-11144
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2019

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: 08/31/2015
• Device Model Number: 1458Q/86
• Device Lot Number: 3805598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 08/10/2019
• Supplement Dates FDA Received: 08/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2012
• 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): Death