MAUDE Adverse Event Report: REMINGTON MEDICAL, INC. DISPOSABLE ADAPTER; CABLE, TRANSDUCER AND ELECTRODE PATIENT (INCLUDING CONNECTOR)

Model Number ADAP-2000(1)

Device Problem Failure to Capture (1081)

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

Event Date 07/26/2019

Event Type  Injury  

Event Description

Temporary pacemaker was inserted and it was not capturing, suspected malfunction of the pacemaker lead.Fda safety report ids# (b)(4).

• Brand Name: DISPOSABLE ADAPTER
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE PATIENT (INCLUDING CONNECTOR)
• Manufacturer (Section D): REMINGTON MEDICAL, INC. ; alpharetta GA 30005
• MDR Report Key: 8865484
• MDR Text Key: 153681896
• Report Number: MW5088790
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/02/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2022
• Device Model Number: ADAP-2000(1)
• Device Lot Number: 1903615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2019
• 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: 78 YR
• Patient Weight: 90