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

Model Number ISOLINE 2CR6

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

Patient Problems Pain (1994); Heart Failure (2206)

Event Date 05/26/2014

Event Type  Injury  

Event Description

The physician reported low impedance and noise sensing relative to the subject lead.It was also indicated that there were 34 inappropriate shocks due to noise sensing.

Event Description

The physician reported low impedance and noise sensing relative to the subject lead.It was also indicated that there were 34 inappropriate shocks due to noise sensing.

• 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 1304 0; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; via crescentino s.n.; .; saluggia 1304 0; IT 13040
• Manufacturer Contact: david thierman ; via crescentino s.n.; .; saluggia 13040 ; IT 13040 ; 0161487077
• MDR Report Key: 3860927
• MDR Text Key: 4512231
• Report Number: 1000165971-2014-00332
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/03/2014

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: 04/04/2014
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/03/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 06/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2011
• 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