MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 3 HF-T DF-1; CRT-D

Model Number 383554

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

Patient Problems Hematoma (1884); Patient Problem/Medical Problem (2688)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.

Event Description

Ous mdr - the patient has a known high inr and thrombocytopenia.Because of this he developed a big hematoma around the scar of the icd.Phenprocoumon was paused for a few days.Within the scope of the bleeding and hematoma the patient had a decreasing hemoglobin from 11 to 9 mg/dl.The patient also developed a high c-reactive protein most likely because of the hematoma.The patient received konakion and unacid.

• Brand Name: IFORIA 3 HF-T DF-1
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6180939
• MDR Text Key: 62561332
• Report Number: 1028232-2016-05007
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 383554
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2016
• 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): Hospitalization