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); High Capture Threshold (3266)

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

Event Date 01/30/2015

Event Type  Injury  

Event Description

Reportedly,during a routine follow-up, a warning message for low impedance (<200 ohms) relative to the subject lead was displayed when interrogating the associated icd.The sensing was normal with a 9mv amplitude wave but the threshold was very high (4.5v) and capture failure was observed.Numerous noisy episodes were also recorded, which did not induce inappropriate therapy.A system revision was performed on the same day.The physician attempted to extract the lead, but the helix would not retract, so it was left in-situ (inactive).A replacement icd system was implanted.The associated icd will be returned for analysis.

Event Description

Reportedly,during a routine follow-up, a warning message for low impedance (<200 ohms) relative to the subject lead was displayed when interrogating the associated icd.The sensing was normal with a 9mv amplitude wave but the threshold was very high (4.5v) and capture failure was observed.Numerous noisy episodes were also recorded, which did not induce inappropriate therapy.A system revision was performed on the same day.The physician attempted to extract the lead, but the helix would not retract, so it was left in-situ (inactive).A replacement icd system was implanted.The associated icd will be returned for analysis.

• 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: 4486146
• MDR Text Key: 5327795
• Report Number: 1000165971-2015-00064
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/30/2015

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: Health Professional
• Device Expiration Date: 06/07/2013
• Device Model Number: ISOLINE 2CR6
• Device Catalogue Number: ISOLINE 2CR6
• Device Lot Number: 2453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/30/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 02/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2010
• 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