FDA Adverse Event Injury Summary report: N

INTERSTIM II

MDR report key: 2951372 · Received February 9, 2013

Report

Report Number: 3004209178-2013-01512
Event Type: Injury
Date Received: February 9, 2013
Report Date: January 22, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: EZW
PMA / PMN Number: P970004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V571447, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. THE DATE OF ON-SET OF THE INFECTION WAS NOTED AS (B)(6) 2011. PATIENT SYMPTOMS OF REDNESS, DRAINAGE WITH ITCHING AND SKIN RASH AT THE INCISIONAL EDGE WERE REPORTED. CULTURES TAKEN OF THE DEVICE POCKET AND SKIN AROUND INCISION HAD NEGATIVE GROWTH. THE INFECTION WAS REPORTED TO BE FUNGAL IN NATURE AND NOT RELATED TO THE INS DEVICE. TREATMENT INSTITUTED FOR THE INFECTION WAS TOTAL EXPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM ALONG WITH ORAL ANTIBIOTICS ADMINISTERED TO THE PATIENT. THE PATIENT OUTCOME WAS REPORTED AS "ONGOING". IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED A YEAR PRIOR TO THE REPORT DUE TO INFECTION. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
56888	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention