FDA Adverse Event Injury Summary report: N

ATTAIN ABILITY

MDR report key: 1992552 · Received February 15, 2011

Report

Report Number: 2649622-2011-02913
Event Type: Injury
Date Received: February 15, 2011
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: OJX
PMA / PMN Number: P080006
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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED). (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED). (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

Description of Event or Problem · 1

IT WAS REPORTED THE LEFT VENTRICULAR LEAD HAD HIGH THRESOLDS. THE LEAD WAS REMOVED. DURING THE ATTEMPTED IMPLANT OF A NEW LEAD, TWO DIFFERENT LEADS HAD NO CAPTURE. THE LEADS WERE NOT USED AND NO NEW LEAD PLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATTAIN ABILITY	IMPLANTABLE PACING LEAD	OJX	MEDTRONIC PUERTO RICO, INC.	4196	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Hospitalization\| R	6947 IMPLANTABLE TACHY LEAD\| 5076 IMPLANTABLE PACING LEAD\| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB