MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number PARADYM CRT-D 8750

Device Problem Reset Problem (3019)

Patient Problem Electric Shock (2554)

Event Date 11/11/2015

Event Type  Injury  

Event Description

Reportedly, patient received a shock on (b)(6) 2015 while undergoing treatment at a chiropractors office.Upon interrogation on (b)(6) 2015, 2 warnings were listed stating that two reset occured since beginning of devices life and that a reset occured on (b)(6) 2015.It was reported that during follow-up testing performed during the interrogation on (b)(6) 2015 the device operated normally with unchanged parameters since the reset.

Manufacturer Narrative

Patient care recommendations have been provided.

Event Description

Reportedly, patient received a shock on (b)(6) 2015 while undergoing treatment at a chiropractors office.Upon interrogation on (b)(6) 2015, 2 warnings were listed stating that two reset occured since beginning of devices life and that a reset occured on (b)(6) 2015.It was reported that during follow-up testing performed during the interrogation on (b)(6) 2015 the device operated normally with unchanged parameters since the reset.

Manufacturer Narrative

Event Description

Reportedly, patient received a shock on (b)(6) 2015 while undergoing treatment at a chiropractors office.Upon interrogation on (b)(6) 2015, 2 warnings were listed stating that two reset occured since beginning of devices life and that a reset occured on (b)(6) 2015.It was reported that during follow-up testing performed during the interrogation on (b)(6) 2015 the device operated normally with unchanged parameters since the reset.

• Brand Name: PARADYM
• Type of Device: DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)
• 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: 5335636
• MDR Text Key: 35171859
• Report Number: 1000165971-2015-00798
• Device Sequence Number: 1
• Product Code: NIK
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2012
• Device Model Number: PARADYM CRT-D 8750
• Device Catalogue Number: PARADYM CRT-D 8750
• Device Lot Number: 2572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/03/2015
• Event Location: Other
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2016; 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2011
• 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