MAUDE Adverse Event Report: PHYSIQUE; PERMANENT PACING LEAD

Model Number SCREWVINE 58 SEP

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

The physician reported that during an implant attempt, blood infiltration was observed within the subject lead during the positioning procedure.Another lead was subsequently implanted instead.

Manufacturer Narrative

Preliminary analysis of the returned lead confirmed the reported blood infiltration through a glue site under the proximal electrode.

Event Description

The physician reported that during an implant attempt, blood infiltration was observed within the subject lead during the positioning procedure.Another lead was subsequently implanted instead.

Manufacturer Narrative

Please refer to the attached investigation report.

Event Description

The physician reported that during an implant attempt, blood infiltration was observed within the subject lead during the positioning procedure.Another lead was subsequently implanted instead.

• Brand Name: PHYSIQUE
• Type of Device: PERMANENT PACING LEAD
• Manufacturer Contact: elodie vincent ; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6075169
• MDR Text Key: 59404029
• Report Number: 1000165971-2016-00675
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SCREWVINE 58 SEP
• Device Catalogue Number: SCREWVINE 58 SEP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/07/2016
• Event Location: Hospital
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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