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

Model Number PARADYM RF DR 9550

Device Problem Failure to Sense (1559)

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

Event Date 04/29/2014

Event Type  Injury  

Event Description

Reportedly, on (b)(6) 2014 an icd implantation was attempted.During implant, the device was being run through a followup prior to dft testing.During the sensitivity test, no r waves were sensed and no deflections were visible on the egm.The lead tested fine through the analyzer and after verifying correct header positioning and set screw manipulation, a new device had to be used.The subject device will be returned for analysis.

Manufacturer Narrative

Preliminary analysis of the returned device confirmed the reported observation that was due to a data corruption.However, after a reinitialization,the device operated as specified.

Event Description

Reportedly, on (b)(6) 2014 an icd implantation was attempted.During implant, the device was being run through a followup prior to dft testing.During the sensitivity test, no r waves were sensed and no deflections were visible on the egm.The lead tested fine through the analyzer and after verifying correct header positioning and set screw manipulation, a new device had to be used.The subject device will be returned for analysis.

Event Description

Reportedly, on (b)(6) 2014, an icd implantation was attempted.During implant, the device was being run through a followup prior to dft testing.During the sensitivity test, no r waves were sensed and no deflections were visible on the egm.The lead tested fine through the analyzer and after verifying correct header positioning and set screw manipulation, a new device had to be used.The subject device will be returned for analysis.

• 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 9214 0; 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: 3822692
• MDR Text Key: 4826363
• Report Number: 1000165971-2014-00288
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2014
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: 2715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/09/2014
• Event Location: Hospital
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2013
• 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