FDA Adverse Event Injury Summary report: N

DISCOVERY

MDR report key: 1852698 · Received October 4, 2010

Report

Report Number: 2124215-2010-14467
Event Type: Injury
Date Received: October 4, 2010
Date of Event: July 14, 2010
Report Date: September 14, 2010
Manufacturer: CPI PLANT - ST. PAUL
Product Code: NVZ
Removal / Correction Number: Z-875/897-03
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THIS DEVICE REMAINS IMPLANTED. AS A RESULT, BOSTON SCIENTIFIC CRM IS UNABLE TO CONFIRM THE CLINICAL OBSERVATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE REOPENED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

Additional Manufacturer Narrative · 1

THIS DEVICE WAS EXPLANTED AND RETURNED. PENDING THE COMPLETION OF LAB ANALYSIS, THIS REPORT WILL BE UPDATED APPROPRIATELY.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. (B)(4).

Description of Event or Problem · 1

INFORMATION WAS LATER RECEIVED THAT THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE HAD BEEN AT END OF LIFE FOR A YEAR AND HALF AS THE PATIENT REFUSED A CHANGE OUT PROCEDURE. THE PATIENT RECENTLY EXPERIENCED A NINE SECOND PAUSE. A CHANGE OUT PROCEDURE HAS BEEN SCHEDULED.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DISCOVERY	IMPLANTABLE PULSE GENERATOR	NVZ	CPI PLANT - ST. PAUL	1274

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Life Threatening	4243\| 1274\| 4285