MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number ISOLINE 2CT6

Device Problems Nonstandard Device (1420); Low impedance (2285)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

It was reported that during a standard follow-up ((b)(6) 2016), the physician observed several low continuity measurements on both coils (less than 200ohms).

• Brand Name: ISOLINE
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; .; saluggia 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; via crescentino s.n.; .; saluggia 13040 ; IT 13040
• Manufacturer Contact: david thierman ; via crescentino s.n.; .; saluggia 13040 ; IT 13040 ; 0161487077
• MDR Report Key: 6105895
• MDR Text Key: 60019446
• Report Number: 1000165971-2016-00724
• Device Sequence Number: 0
• Product Code: MRM
• Reporter Country Code: PO
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2008
• Device Model Number: ISOLINE 2CT6
• Device Catalogue Number: ISOLINE 2CT6
• Device Lot Number: 2150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/27/2016
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2006
• 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