ADAPTA DR

MDR report key: 2082947 · Received May 10, 2011

Report

Report Number: 2647346-2011-00661
Event Type: Injury
Date Received: May 10, 2011
Date of Event: April 25, 2011
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: NVZ
PMA / PMN Number: P980035/S043
Removal / Correction Number: ASKU
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ASKU

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 REPORTED THE PATIENT WAS EXPERIENCING PECTORAL STIMULATION NEAR THE DEVICE POCKET WHEN RAISING ARM ABOVE HEAD. IMPEDANCES AT IMPLANT HAD BEEN 600 -700 OHMS AND NOW ARE 400 - 500 OHMS. PROVOCATIVE TESTING WAS DONE IN THE CLINIC. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS NOT PACER DEPENDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT WAS EXPERIENCING PECTORAL STIMULATION NEAR THE DEVICE POCKET WHEN RAISING ARM ABOVE HEAD. IMPEDANCES AT IMPLANT HAD BEEN 600 -700 OHMS AND NOW ARE 400 - 500 OHMS. PROVOCATIVE TESTING WAS DONE IN THE CLINIC. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS NOT PACER DEPENDENT. FOLLOW UP REVEALED THE PHYSICIAN IS STILL OBSERVING THE PATIENT BEFORE HE TAKES HIM BACK TO THE CATH LAB.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ADAPTA DR	IMPLANTABLE PULSE GENERATOR	NVZ	MEDTRONIC MED REL, INC.	ADDR01	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR		Other\| R	3830 IMPLANTABLE PACING LEAD\| 3830 IMPLANTABLE PACING LEAD