MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR); DUAL CHAMBER PULSE GENERATOR

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

Patient Problems Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-06670.It was reported that a patient experienced erythema around the pacemaker pocket and wound dehiscence of the surgical site 15 days after being implanted with a new pacemaker in (b)(6) 2018.The patient underwent antibiotic regimens for a year and a half, with the patient's pacemaker being explanted, replaced and treated with antibiotics on (b)(6) 2020.The new pacemaker later exteriorized one month after this, prompting this pacemaker to also be explanted and replaced.Dermal tests identified that the patient's body was rejecting the nickel in the pacemakers.

Manufacturer Narrative

Further information was requested, but not received.

• Type of Device: DUAL CHAMBER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13952674
• MDR Text Key: 288273156
• Report Number: 2017865-2022-06685
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2022
• 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