FDA Adverse Event Injury Summary report: N

INTERSTIM II

MDR report key: 3308402 · Received August 26, 2013

Report

Report Number: 3004209178-2013-15167
Event Type: Injury
Date Received: August 26, 2013
Report Date: July 30, 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: OR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 889-28, LOT# V900199, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS FURTHER REPORTED ALL THE IMPEDANCES WERE ¿ABOVE LIMITS¿. IT WAS NOTED THE PATIENT HAD ¿NO SENSATION¿ AND ALL THE IMPEDANCES WERE ¿BEYOND LIMITS¿. IT WAS FURTHER NOTED THE PATIENT HAD AN X-RAY AND IT WAS DETERMINED THE LEADS WERE IN PLACE. IT WAS NOTED THE INS WAS REPLACED ON (B)(6) 2013 WITH ¿GOOD RESPONSE¿. IT WAS ALSO NOTED THAT THE PATIENT REQUIRED HOSPITALIZATION AND THE PATIENT REPORTEDLY RECOVERED WITHOUT SEQUELAE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DOCTOR WANTED TO REPLACE THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE REPORTER DID NOT KNOW WHAT WAS WRONG. IT WAS FURTHER NOTED THAT THE REPORTER DID NOT KNOW WHEN THE PROBLEM STARTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANT WAS TO BE REPLACED IN AUGUST. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
417716	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R