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

Model Number SYMPHONY DR 2550

Device Problem Low Battery (2584)

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

Event Date 07/19/2017

Event Type  Injury  

Event Description

Reportedly, the device was last checked on (b)(6) 2017 at which time the battery impedance was 5.67ko and the programmer software provided a time to eri estimate of 17 months.On (b)(6) 2017, the device was found to have reached rrt with a battery impedance of (b)(6).The patient was undergoing treadmill testing during which it was observed the patient¿s cardiac rate was not increasing sufficiently during the exercise so, it was decided to check the pacemaker.When the device was interrogated, it was observed that it was operating in nominal settings due to having reached rrt.It was not suspected that the programming or usage of the device would have changed significantly since the (b)(6) 2017 follow-up.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, the device was last checked on (b)(6) 2017 at which time the battery impedance was 5.67kohms and the programmer software provided a time to eri estimate of 17 months.On (b)(6) 2017, the device was found to have reached rrt with a battery impedance of 11.42kohms.The patient was undergoing treadmill testing during which it was observed the patient's cardiac rate was not increasing sufficiently during the exercise so, it was decided to check the pacemaker.When the device was interrogated, it was observed that it was operating in nominal settings due to having reached rrt.It was not suspected that the programming or usage of the device would have changed significantly since the (b)(6) 2017 follow-up.

• Brand Name: SYMPHONY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN CRM; parc d'affaires noveos; 4 avenue reaumur; clamart, 92140 ; FR 92140
• Manufacturer (Section G): SORIN CRM 98, RUE MAURICE ARNOUX 92120; parc d'affaires noveos; 4 avenue reaumur; clamart, 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos; 4 avenue reaumur; clamart, 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6730416
• MDR Text Key: 80622984
• Report Number: 1000165971-2017-00581
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/19/2017

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: 09/29/2009
• Device Model Number: SYMPHONY DR 2550
• Device Catalogue Number: SYMPHONY DR 2550
• Device Lot Number: M080317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/19/2017
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 10/31/2017
• Supplement Dates FDA Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2008
• 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): Life Threatening; Required Intervention