MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INOGEN; IMPLANTABLE CHF GENERATOR

Model Number G140

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Discharge (2225); Post Operative Wound Infection (2446); Blood Loss (2597)

Event Date 06/24/2016

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that two weeks after epicardial lead placement, the patient was admitted into the emergency room (er) due to a surgical incision site opening with serous sanguineous fluid drainage; the suspected cause of the seroma in the left breast was post-operative.It was noted that the patient was admitted to the er and discharged on the same day.During a follow-up appointment, an in-office draining was performed, the wound was cleaned with povidone-iodine, and the wound was loosely dressed; no antibiotics or other interventions were necessary.The patient was later seen for follow-up, and the seroma had resolved.This cardiac resynchronization therapy defibrillator (crt-d) remains in service.There were no additional adverse effects reported.

• Brand Name: INOGEN
• Type of Device: IMPLANTABLE CHF GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6281120
• MDR Text Key: 65864939
• Report Number: 2124215-2017-01214
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: (01)00802526534539(17)20170916
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/16/2017
• Device Model Number: G140
• Other Device ID Number: INOGEN CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2015
• 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
• Treatment: 0696; 4046; 4674; 5076; D152; G140
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 65 YR