FDA Adverse Event Injury Summary report: N

SELECT SECURE

MDR report key: 2040438 · Received April 5, 2011

Report

Report Number: 2649622-2011-04409
Event Type: Injury
Date Received: April 5, 2011
Date of Event: March 21, 2011
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: NVN
PMA / PMN Number: P030036
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS NO CAPTURE AND NO SENSING OF THE LEAD. IT WAS FURTHER REPORTED THAT THE LEAD WAS COILED BEHIND THE DEVICE AND PULLED COMPLETELY THROUGH THE SUTURE SLEEVE WHICH REMAINED SUTURED IN PLACE. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

ASKU

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SELECT SECURE	IMPLANTABLE PACING LEAD	NVN	MEDTRONIC PUERTO RICO, INC.	3830	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	13 YR		Hospitalization\| R	(B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB\| 6935 IMPLANTABLE TACHY LEAD\| 6935 IMPLANTABLE TACHY LEAD\| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB