MAUDE Adverse Event Report: MEDTRONIC, INC. DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5392

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Mechanical Problem (1384); Component Missing (2306); Connection Problem (2900); Device Sensing Problem (2917)

Patient Problem Ectopic Heartbeat (4443)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: analysis was unable to confirm the customer comment that the external pulse generator (epg) had a sensitivity issue.It was confirmed that the patient connectors were broken and gasket was exposed.Upper and lower case halves were damaged.It was further noted that the keyboard was scratched and four case screws and hanger screw were contaminated.The main seal was pinched.All found defective parts were replaced and all other identified issues were resolved.The epg then passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that when the external pulse generator (epg) was being used on a patient post-operatively the clinician was unable to use the epg setting on monitor due to electrical interference.The epg was set to dual pacing mode of 50.It was reported the patient started to have increased ectopy whilst heart rate remained unchanged in the 80¿s.It was noted that upon examination the epg was pacing but not sensing.It was further noted that once the wires were removed from the epg the ectopy stopped.The cardiac monitor electrocardiogram (ecg) rhythm was very noisy and had several pacing flags even after the epg was disconnected.No further patient complications have been reported as a result of this event.

• Brand Name: DUAL CHAMBER TEMPORARY PACEMAKER
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11863062
• MDR Text Key: 251945359
• Report Number: 2182208-2021-02085
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169725126
• UDI-Public: 00643169725126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention