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

Model Number PARADYM DR 8550

Device Problem Pacing Problem (1439)

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

Event Date 07/20/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, patient presented to hospital with slow vt.Physician could reportedly not deliver anti-tachycardia pacing (atp therapy) through the programmer.

Manufacturer Narrative

According to preliminary analysis of provided files, the reported behavior was not confirmed.A hypothesis could be that manual atp therapy deactivation was performed on (b)(6) 2015; but this cannot be confirmed from available data.Atp therapy was successfully reprogrammed on during the follow-up on (b)(6) 2015.

Event Description

On (b)(6) 2015, patient presented to hospital with slow vt.Physician could reportedly not deliver anti-tachycardia pacing (atp therapy) through the programmer.

Event Description

On (b)(6) 2015, patient presented to hospital with slow vt.Physician could reportedly not deliver anti-tachycardia pacing (atp therapy) through the programmer.

Manufacturer Narrative

New follow-up data have been provided for analysis.Therefore, the complaint file has been reopened.

Event Description

On (b)(6) 2015, patient presented to hospital with slow vt.Physician could reportedly not deliver anti-tachycardia pacing (atp therapy) through the programmer.

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2015, patient presented to hospital with slow vt.Physician could reportedly not deliver anti-tachycardia pacing (atp therapy) through the programmer.

• 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 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 5004524
• MDR Text Key: 23043115
• Report Number: 1000165971-2015-00495
• 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
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2013
• Device Model Number: PARADYM DR 8550
• Device Catalogue Number: PARADYM DR 8550
• Device Lot Number: 2586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/20/2015
• Event Location: Hospital
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2012
• 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): Required Intervention