INTERSTIM II

MDR report key: 3923708 · Received July 9, 2014

Report

Report Number: 3004209178-2014-12759
Event Type: Injury
Date Received: July 9, 2014
Date of Event: June 16, 2014
Report Date: June 27, 2016
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: MI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3889-28, LOT# V667635, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. NO INTERVENTIONS WERE REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS PAIN AT THE IMPLANT SITE. IT WAS NOTED THAT THE OUTCOME WAS ONGOING. IT WAS NOTED THAT THE PATIENT COUNSELED ABOUT POSITIONING TO AVOID IRRITATING THE SITE UNTIL SURGERY COULD BE SCHEDULED TO REPOSITION OR REPLACE THE DEVICE. IT WAS NOTED THAT THE PATIENT EXPRESSED DISCOMFORT AT THE SITE FOLLOWING RECENT WEIGHT LOSS. IT WAS NOTED THAT THE DEVICE SITE WAS PALPATED AND WAS SUPERFICIALLY POSITIONED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS EVALUATED FURTHER AND DETERMINED THAT REPOSITIONING OF DEVICE WOULD NOT BE BENEFICIAL SINCE THE PATIENT¿S WEIGHT HAD CAUSED HER TO NOT HAVE ENOUGH TISSUE TO PLACE THE DEVICE DEEPER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
400189	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1	00059 YR		Required Intervention