CAPSURE SP NOVUS

MDR report key: 2790811 · Received October 15, 2012

Report

Report Number: 2649622-2012-14776
Event Type: Malfunction
Date Received: October 15, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: DTB
PMA / PMN Number: P830061/S27
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS LATER REPORTED THAT THERE WAS AN ATRIAL LEAD WARNING FOR LOW IMPEDANCE PACES, FAR FIELD R-WAVE (FFRW) OVERSENSING, MODE SWITCH EPISODES AND NOTED ATRIAL HIGH RATE EPISODES (AHRE) RECORDED. RECOMMENDATION IS TO ADJUST ATRIAL SENSITIVITY TO SEE IF FFRW GOES AWAY WHILE MAINTAINING ADEQUATE SAFETY MARGIN FOR SENSING. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS SEEN POST EPISODE OF PRE-SYNCOPE AND UPON INTERROGATION IT WAS NOTED THAT DURING ATRIAL OVERSENSING MODE SWITCH WAS INAPPROPRIATELY ACTIVATED. NOISE COULD BE RULED OUT ON THE ATRIAL HIGH RATES STORED ON THE ELECTROGRAM. IT WAS FURTHER REPORTED THAT THERE WAS A PERIOD OF NOISE AND OVERSENSING WHEN TRYING TO REPROGRAM BACK TO A BIPOLAR CONFIGURATION. THE PATIENT REMAINS PROGRAMMED UNIPOLAR AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CAPSURE SP NOVUS	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC PUERTO RICO, INC.	4592

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Life Threatening\| R	(B)(4) IMPLANTABLE PULSE GENERATOR\| 4092 IMPLANTABLE PACING LEAD