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 Problem No Information (3190)

Event Date 02/17/2015

Event Type  Injury  

Event Description

The physician reported that during a regular follow-up, a warning message showing low rv coil continuity (<200ohms) and low svc coil continuity (209 ohms) were displayed in relation to the subject lead.Punctual measurements were all around 400ohms, which were about the same values obtained at the previous follow-up.A decreasing trend to these coil continuity and pacing impedance measurements was also indicated.Recorded episodes showed noise sensing, even though there was no inappropriate shock.Since no therapy has been delivered since the implantation, the shock therapy was re-programmed to off and a re-intervention was scheduled.Prior to the re-intervention, oversensing, low coil continuity, and low pacing impedance measurements were again noted.Psa measurements relative to the subject lead were not made.The connector portion of the lead was sectioned, explanted and discarded, while the distal section was left in-situ.

Event Description

The physician reported that during a regular follow-up, a warning message showing low rv coil continuity (<200ohms) and low svc coil continuity (209 ohms) were displayed in relation to the subject lead.Punctual measurements were all around 400ohms, which were about the same values obtained at the previous follow-up.A decreasing trend to these coil continuity and pacing impedance measurements was also indicated.Recorded episodes showed noise sensing, even though there was no inappropriate shock.Since no therapy has been delivered since the implantation, the shock therapy was re-programmed to off and a re-intervention was scheduled.Prior to the re-intervention, oversensing, low coil continuity, and low pacing impedance measurements were again noted.Psa measurements relative to the subject lead were not made.The connector portion of the lead was sectioned, explanted and discarded, while the distal section was left in-situ.

• 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 1304 0; IT 13040
• Manufacturer Contact: david thierman ; via crescentino s.n.; .; saluggia 13040 ; IT 13040 ; 0161487077
• MDR Report Key: 4576344
• MDR Text Key: 5560162
• Report Number: 1000165971-2015-00124
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP980049
• 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,Followup
• Report Date: 02/19/2015

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: Physician
• Device Expiration Date: 11/18/2012
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/19/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2010
• 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