INTERSTIM II

MDR report key: 3062742 · Received April 17, 2013

Report

Report Number: 3004209178-2013-06421
Event Type: Injury
Date Received: April 17, 2013
Date of Event: March 29, 2013
Report Date: April 23, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: EZW
PMA / PMN Number: P970004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V955729, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT WAS USING MICROSTIM BECAUSE THEY HURT THEIR SHOULDER. SINCE STARTING THE THERAPY, ABOUT A WEEK PREVIOUS, THE PATIENT HAD STARTED TO CATHETERIZE A "BIT MORE." IT WAS UNCLEAR IF THE MICROSTIM WAS AFFECTING THE PERFORMANCE OF THE DEVICE. IT WAS STATED THE PATIENT WOULD GO "THROUGH CYCLES, BUT IT SEEMED MORE THIS TIME." IT WAS INDICATED THE PATIENT "CONSTANTLY" HAD INFECTIONS AND THEY WERE NOT BEING TREATED. IT WAS NOTED THE PATIENT WAS GOING TO SEE THEIR HEALTHCARE PROVIDER ABOUT THEIR SYMPTOMS. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR PHYSICIAN OR THE MANUFACTURER'S REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
166259	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1	00038 YR		Required Intervention