MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC DUAL CHAMBER TEMPORARY PACEMAKER

Model Number 5388

Device Problems Pacemaker Found in Back-Up Mode (1440); No Pacing (3268)

Patient Problems Cardiopulmonary Arrest (1765); Failure of Implant (1924)

Event Date 09/26/2019

Event Type  Injury  

Event Description

The patient has a past medical history of non-ischemic cardiac disease and severe aortic stenosis.He was transferred from an outside hospital and underwent tavr (transcatheter aortic valve replacement) with temporary pacing wire insertion on (b)(6) 2019.On the morning of (b)(6) 2019, nursing staff changed the battery per protocol.The battery was checked at the beginning and end of each shift by two registered nurses and the rate was 70, milliamps 5 and millivolts 0.8.At approximately 8:15am, the pacemaker spontaneously stopped, the patient developed asystole and cpr was initiated.Return of circulation occurred in approximately 90 seconds with a heart rate of 50.The pacemaker then spontaneously paced and the default setting of 80 bpm was noted, although the heart rate had been set at 70 bpm.The patient was alert, oriented and with stable vital signs.At approximately 12:15pm, the electrophysiology (ep) team arrived to transport the patient to the ep lab for placement of a permanent pacemaker.The patient was attached to a zoll.It was again noted that the patient was asystolic.Cpr was initiated for approximately 15 seconds and the patient was then transcutaneously paced via the zoll.A permanent pacemaker was placed.The patient was alert, oriented and was discharged in stable condition on (b)(6) 2019.

• Brand Name: MEDTRONIC DUAL CHAMBER TEMPORARY PACEMAKER
• Type of Device: TEMPORARY PACEMAKER
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432 5604
• MDR Report Key: 9203102
• MDR Text Key: 163127512
• Report Number: 9203102
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5388
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2019
• Distributor Facility Aware Date: 09/26/2016
• Device Age: 150 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 71