MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC 5388 EXTERNAL PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5388

Device Problems No Display/Image (1183); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2013

Event Type  malfunction  

Event Description

An infant with a history of l-transposition of the great vessels, ebsteinoid tricuspid (systemic) valve, ventricular septal defect, atrial septal defect and patent ductus arteriosus was admitted at birth.Patient was status post placement of pulmonary artery band, ligation of pda, ventricular septal defect enlargement, patch closure of the tricuspid valve, atrial septectomy and tracheostomy.The patient had complete heart block, and so was pacemaker dependent.The pacemaker was due for a battery change.In preparation for the procedure, a second pacemaker was at the bedside and set for the patient's parameters.The back-up pacemaker's batteries were changed first.During the primary pacemaker's battery change, once the battery was placed in the pacemaker, the pacemaker's screen went blank and the patient's monitor showed asystolic heart rhythm.The patient's arterial waveform went flat.The staff quickly changed to the back-up pacemaker and so the patient did not suffer any ill-effects.The pacemaker was sent to biomed for evaluation.

• Brand Name: MEDTRONIC 5388 EXTERNAL PACEMAKER
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 5258978
• MDR Text Key: 32507741
• Report Number: 5258978
• Device Sequence Number: 1
• Product Code: DTE
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• 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: 08/30/2013
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2013
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 4