MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 062918

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Fibrillation (1729)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).The device manufacturer and lot number of the j tube involved in this event was not provided by the complainant.Therefore, it is unknown if the tubing involved was the abbvie j tube.Abbvie has chosen to report this event due to the potential that the j tube involved could have been the abbvie j tube.The device involved in the event was not returned; therefore a return sample evaluation is unable to be performed.Atrial fibrillation was a procedure related event.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, patient underwent procedure for the placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.The report indicated that patient was hospitalized for two weeks for j tube replacement in (b)(6) 2020.Daughter reported that the patient developed atrial fibrillation during j tube replacement and the j tube was removed.It was reported that the atrial fibrillation was managed with eliquis and digoxin.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer (Section G): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer Contact: terry ingram ; 1675 lakeside drive; waukegan, IL 60085 ; 8479385350
• MDR Report Key: 11340168
• MDR Text Key: 232337827
• Report Number: 3010757606-2021-00118
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 062918
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 67 YR