FDA Adverse Event Injury Summary report: N

SYMPHONY

MDR report key: 1936314 · Received December 15, 2010

Report

Report Number: 9610579-2010-00636
Event Type: Injury
Date Received: December 15, 2010
Date of Event: December 3, 2010
Report Date: December 6, 2010
Manufacturer: SORIN CRM
Product Code: NVZ
PMA / PMN Number: P950029
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. (OTHER): THE PROGRAMMER FILES WERE REVIEWED. CONCLUSION: EPISODES RECORDED ON (B)(6) 2010, REVEALED PRESENCE OF NON PHYSIOLOGICAL SIGNALS; BECAUSE OF THESE OVERSENSING EVENTS, PACING WAS INHIBITED. THIS PHENOMENON COULD BE RELATED TO A CONNECTION ISSUE, OR MORE PROBABLY TO A LEAD ISSUE (INSULATION OR CONDUCTOR FRACTURE). BECAUSE OF HIGH FREQUENCY OF THIS PHENOMENON, EVALUATION OF A RE-INTERVENTION SHOULD BE CONSIDERED TO CHECK PROPER LEAD OPERATION (VISUAL CHECK, ELECTRICAL TESTS / SENSING TEST LEAD DISCONNECTED).

Description of Event or Problem · 1

REPORTEDLY, THE PATIENT WAS SYMPTOMATIC. ON (B)(6) 2010, AT THE FOLLOW-UP, THE PHYSICIAN HAS OBSERVED THAT VENTRICULAR RUNS DATED (B)(6) 2010 WERE RECORDED IN THE HOLTER MEMORY. THE PHYSICIAN HAS PERFORMED PROVOCATIVE TESTING TO REPRODUCE THE OBSERVED EPISODES WITHOUT SUCCESS. THE PHYSICIAN REQUESTED ANALYSIS OF THESE EPISODES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYMPHONY		NVZ	SORIN CRM	SYMPHONY DR 2550	M050202

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention