ATTAIN ABILITY

MDR report key: 3861805 · Received June 10, 2014

Report

Report Number: 2649622-2014-07166
Event Type: Injury
Date Received: June 10, 2014
Date of Event: April 28, 2014
Report Date: April 28, 2014
Manufacturer: MPRI
Product Code: OJX
PMA / PMN Number: P080006
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4)

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID D224TRK ICD, IMPLANTED: (B)(6) 2011; 407645 LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

Description of Event or Problem · 1

IT WAS ALSO REPORTED THE PATIENT EXPERIENCED DIAPHRAGMATIC AND EXTRACARDIAC STIMULATION. THE PATIENT WAS ENROLLED IN THE PRODUCT SUR VEILLANCE REGISTRY CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD THRESHOLD INCREASED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
341821	ATTAIN ABILITY	DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE	OJX	MPRI	419688

Patients

Seq	Age	Sex	Outcome	Treatment
1	00062 YR		Hospitalization\| R	694758 LEAD