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

Model Number PARADYM VR 8250

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 on right ventricular lead was displayed when interrogating the subject 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 recorded more likely due to noise related to a lead issue (without therapies delivered).A system revision was performed on the same day.The physician tried to explant the lead but the helix didn¿t collect.He implanted a new lead.The physician chose to replace also the icd (magnet period was at 87 min-1) to prevent the patient to be reviewed in a delay.The subject icd will be returned for analysis.

Event Description

Reportedly,during a routine follow-up, a warning message for low impedance on right ventricular lead was displayed when interrogating the subject 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 recorded more likely due to noise related to a lead issue (without therapies delivered).A system revision was performed on the same day.The physician tried to explant the lead but the helix didn¿t collect.He implanted a new lead.The physician chose to replace also the icd (magnet period was at 87 min-1) to prevent the patient to be reviewed in a delay.The subject icd will be returned for analysis.

Event Description

Reportedly,during a routine follow-up, a warning message for low impedance on right ventricular lead was displayed when interrogating the subject 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 recorded more likely due to noise related to a lead issue (without therapies delivered).A system revision was performed on the same day.The physician tried to explant the lead but the helix didn¿t collect.He implanted a new lead.The physician chose to replace also the icd (magnet period was at 87 min-1) to prevent the patient to be reviewed in a delay.The subject icd will be returned for analysis.

Manufacturer Narrative

Preliminary analysis of he returned device did not reveal any anomaly.

• Brand Name: PARADYM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 4477589
• MDR Text Key: 5326970
• Report Number: 1000165971-2015-00060
• 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
• Type of Report: Initial,Followup,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: 10/23/2011
• Device Model Number: PARADYM VR 8250
• Device Catalogue Number: PARADYM VR 8250
• Device Lot Number: 2487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/30/2015
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/31/2015; 04/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention