MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL ISOLINE

Model Number ISOLINE 2CR6

Device Problems Over-Sensing (1438); Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2013

Event Type  Injury  

Event Description

The physician reported very low impedance and very high threshold measurements relative to the subject lead.Oversensing was also reportedly observed.The subject lead was explanted.

Manufacturer Narrative

This event concerns a device that was manufactured and used outside the united states.Analysis is pending.

• Brand Name: ISOLINE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; via crescentino s.n.; saluggia (vc) 1304 0; IT 13040
• Manufacturer Contact: d thierman ; via crescentino s.n.; saluggia (vc) 13040 ; IT 13040 ; 46013687
• MDR Report Key: 3597276
• MDR Text Key: 21052456
• Report Number: 1000165971-2014-00037
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/24/2014,12/30/2013

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 Operator: Health Professional
• Device Expiration Date: 10/30/2009
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/30/2013
• Initial Date FDA Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0928-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention