MAUDE Adverse Event Report: INVIVO CORPORATION INVIVO; SENTINELLE BREAST COIL

Model Number SENTINELLE SMS SKYRA 3T 8CH BREAST COIL

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

Patient Problem Multiple Fractures (4519)

Event Date 11/16/2022

Event Type  Injury  

Manufacturer Narrative

This incident was already reported to the fda by siemens under 3002808157-2022-54760.As the manufacturer of the coil that was used at the time of the incident philips has also decided to inform the fda of this incident.However, from the information received from siemens it is clear that the incident was caused by a malfunction of the patient table of the siemens mr system where the coil was used in.Philips will therefore perform no further investigation into this incident.

Event Description

Philips received a report from a 3rd party customer, (b)(6) gmbh mr, that a patient suffered multiple rib fractures whilst being examined on an magnetom symphony a tim using a sentinelle breast coil.

• Brand Name: INVIVO
• Type of Device: SENTINELLE BREAST COIL
• Manufacturer (Section D): INVIVO CORPORATION; 3545 sw 47th ave; gainesville FL 32608
• Manufacturer (Section G): INVIVO CORPORATION; 3545 sw 47th ave; gainesville FL 32608
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 16407311
• MDR Text Key: 309863181
• Report Number: 1056069-2023-00001
• Device Sequence Number: 1
• Product Code: MOS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: SENTINELLE SMS SKYRA 3T 8CH BREAST COIL
• Device Catalogue Number: 453530384591
• Initial Date Manufacturer Received: 02/11/2023
• Initial Date FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 89 KG