FDA Adverse Event Injury Summary report: N

UNKNOWN INTERSTIM

MDR report key: 2854700 · Received December 3, 2012

Report

Report Number: 3007566237-2012-02893
Event Type: Injury
Date Received: December 3, 2012
Date of Event: November 8, 2012
Report Date: November 8, 2012
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: EZW
PMA / PMN Number: P970004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE EXTENSION PRODUCT ID 3093-28, LOT# V813549, IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

ANALYSIS OF THE LEAD (PRODUCT# 3093-28, LOT# V813549) FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION FOUND NO SIGNIFICANT ANOMALY. THE EXTENSION BODY WAS CUT THROUGH, PRODUCT SEGMENTED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION INDICATED THE PATIENT DID NOT RESPOND TO THERAPY.

Description of Event or Problem · 1

IT WAS REPORTED THE LEAD LOOKED LIKE FLUID/BLOOD HAD PENETRATED THE INNER HOUSING OF THE LEAD/ HEALTH CARE PROFESSIONAL QUESTIONED THE INTEGRITY OF THE LEAD INSULATION. LEAD WAS EXPLANTED. THERE WERE NO INJURIES, SYMPTOMS, OR ADVERSE EVENTS TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNKNOWN INTERSTIM	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC NEUROMODULATION	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	00083 YR		Required Intervention