MAUDE Adverse Event Report: MPRI SPRINT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6945

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

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Skin Discoloration (2074); Chills (2191); Discomfort (2330); Coma (2417); Valvular Insufficiency/ Regurgitation (4449); Swelling/ Edema (4577)

Event Date 11/18/2009

Event Type  Injury  

Manufacturer Narrative

The initial reported event of infection was submitted via an alternative summary report.As the summary report has been revoked, this new information is therefore being submitted via a 30 day report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that about a week after the implantable cardioverter defibrillator (icd) was implanted the implant site was sore and had a pale discoloration.Several weeks later the patient had fever and chills.The patient went to the hospital.At the hospital it was observed that puss oozed from the implant site when pressure was applied.It was found that the patient had an staph infection.Antibiotics were administered, and the icd system was explanted.After the explant the patient had internal bleeding and more surgery was needed.The patient was in a coma for about one month.After waking up the patient remained in the hospital due to venous insufficiency in the brain, and swelling in multiple areas of the body including head and arms.The patient was eventually discharged, and later the icd system was replaced.

• Brand Name: SPRINT
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14163659
• MDR Text Key: 289699003
• Report Number: 2649622-2022-07586
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2003
• Device Model Number: 6945
• Device Catalogue Number: 6945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Date Device Manufactured: 07/27/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: D224VRC ICD
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male