FDA Adverse Event Injury Summary report: N

ADAPTA DR

MDR report key: 3277953 · Received August 10, 2013

Report

Report Number: 2182208-2013-02225
Event Type: Injury
Date Received: August 10, 2013
Date of Event: June 1, 2013
Report Date: June 12, 2013
Manufacturer: MEDTRONIC, INC.
Product Code: NVZ
PMA / PMN Number: P980035
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. AN EMAIL WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF YET. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: ¿SAFETY OF REPETITIVE NERVE STIMULATION IN PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES. MUSCLE NERVE. JUNE 1 2013;47(6):840-844. (B)(4).

Description of Event or Problem · 1

A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT UNDERWENT A REPETITIVE NERVE STIMULATION (RNS) PROCEDURE. THE ICD DETECTED THE ELECTROMAGNETIC INTERFERENCE (EMI), AND PACING INHIBITION OF THE VENTRICULAR OUTPUT WAS OBSERVED FOR SIX SECONDS. THE ICD WAS INTERROGATED AFTER THE PROCEDURE AND THERE WERE NO ADVERSE EVENTS. THE ICD 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
382768	ADAPTA DR	PULSE GENERATOR, PERMANENT, IMPLANTABLE	NVZ	MEDTRONIC, INC.	ADDR01

Patients

Seq	Age	Sex	Outcome	Treatment
1	00071 YR		Hospitalization