MAUDE Adverse Event Report: ETHICON INC. TEMPORARY PACING WIRE UNKNOWN PRODUCT; ELECTRODE, PACEMAKER, TEMP.

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

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This report is related to data research, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).Device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported via clinical evaluation report from a related research activity database (drra) that patients underwent an unknown procedure on an unknown date and suture was used.The reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 1,878 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, use of temporary pacemaker.680 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, infection.274 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, pericarditis.101 patients had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, open removal of cardiac lead.No additional information was provided.

• Brand Name: TEMPORARY PACING WIRE UNKNOWN PRODUCT
• Type of Device: ELECTRODE, PACEMAKER, TEMP.
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14496538
• MDR Text Key: 292608732
• Report Number: 2210968-2022-04066
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention