MAUDE Adverse Event Report: SORIN CRM SYMPHONY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number RHAPSODY + DR 2530

Device Problem Pacing Inadequately (1442)

Patient Problem Heart Failure (2206)

Event Date 12/21/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient was reportedly admitted at hospital, for heart failure and a constant pacing rate at 120min-1.The minute ventilation sensor was deactivated; the rate subsequently decreased down to 70min-1.An explanation was requested.On (b)(6) 2015, the pacemaker was operating in fallback mode upon interrogation.During the session, the pacing rate reportedly varied from 70 min-1 to 100min-1 and back to 70min-1.This occurred several times and was unexpected.An explanation was requested.

Manufacturer Narrative

Regarding the pacing rate at 120min-1 observed on (b)(6) 2015 while the mv sensor was activated: preliminary analysis showed that it may be related to an issue with mv sensor.Regarding the ventricular pacing rate variations observed during the follow-up on (b)(6) 2015 while the patient was in atrial arrhythmia: preliminary analysis showed that the pacemaker operated as specified.

Event Description

On (b)(6) 2015, the patient was reportedly admitted at hospital, for heart failure and a constant pacing rate at 120min-1.The minute ventilation sensor was deactivated; the rate subsequently decreased down to 70min-1.An explanation was requested.On (b)(6) 2015, the pacemaker was operating in fallback mode upon interrogation.During the session, the pacing rate reportedly varied from 70 min-1 to 100min-1 and back to 70min-1.This occurred several times and was unexpected.An explanation was requested.

Event Description

On (b)(6) 2015, the patient was reportedly admitted at hospital, for heart failure and a constant pacing rate at 120min-1.The minute ventilation sensor was deactivated; the rate subsequently decreased down to 70min-1.An explanation was requested.On (b)(6) 2015, the pacemaker was operating in fallback mode upon interrogation.During the session, the pacing rate reportedly varied from 70 min-1 to 100min-1 and back to 70min-1.This occurred several times and was unexpected.An explanation was requested.

• Brand Name: SYMPHONY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN CRM; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN CRM 98, RUE MAURICE ARNOUX 92120 MONTROUGE FRANCE; 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: 5331978
• MDR Text Key: 34574534
• Report Number: 1000165971-2015-00794
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PP950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2015

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: Physician
• Device Expiration Date: 11/17/2009
• Device Model Number: RHAPSODY + DR 2530
• Device Catalogue Number: RHAPSODY + DR 2530
• Device Lot Number: S080506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/22/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/22/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/02/2016; 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2008
• 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