MAUDE Adverse Event Report: LIVANOVA USA, INC. UNKNOWN

Catalog Number 656631

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The reported part number (656631) does not exist in the livanova usa catalog.The device product code selected is based off of the user medwatch report received.It is unknown if this code truly reflects the function of the involved product.The reported part number (656631) does not exist in the livanova usa catalog, and the reported lot number corresponds to part number 401208011, which is a white protector for pts packs, which is different than the part number and product code (catheter) indicated in the user report.Additionally, this is an internal lot number for a sub-component of a convenience pack, and the end user would not have visibility to this part number.The user report did not indicate any hospital or initial reporter information.As the reported catalog number is not a livanova usa part, the 510(k) number could not be determined.As the reported catalog number is not a livanova usa part, and the reported log number does not match the product description in the report, it is unknown if this is a livanova usa lot number, and the manufacture date is unknown.As there is no contact or hospital information provided in the user medwatch report, and the reported catalog and lot number do not appear to belong to a livanova usa product, no further investigation could be performed.It is unknown why the device was still used following the discovery of the insect, and it is unknown if the insect was discovered within the sterile packaging or if it was in the outer shipping box.If any additional information pertinent to the reported event is received, it will be submitted in a supplemental report.

Event Description

On (b)(6) 2018, livanova received a user medwatch report (mw5074124) stating that a roach was found in product.The report indicated that the product was still used.Though the report stated that the product was still used, it was indicated that there was no adverse event.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7232286
• MDR Text Key: 98756775
• Report Number: 1718850-2018-00004
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 656631
• Device Lot Number: 1716400136
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1