FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 3781119 · Received April 30, 2014

Report

Report Number: 3004209178-2014-08286
Event Type: Injury
Date Received: April 30, 2014
Date of Event: July 7, 2013
Report Date: April 8, 2014
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

A CSF LEAK WAS REPORTED. THE SYMPTOMS THE PATIENT EXPERIENCED WERE SPINAL HEADACHE, ASSOCIATED NAUSEA AND VOMITING. IT WAS NOTED THE HEADACHE BETTER WHEN LAYING DOWN. ETIOLOGY WAS INDICATED INTRATHECAL SITE NOTED TO BE RELATED TO THE IMPLANT PROCEDURE. THE SEVERITY WAS INDICATED A MILD. DIAGNOSTIC METHODS PERFORMED ON (B)(6) 2013 INCLUDED EXAMINATION/PALPATION. INTERVENTION INCLUDED A BLOOD PATCH AT THE SITE OF THE CSF LEAK. EXAMINATION PERFORMED ON (B)(6) 2013 REVEALED PATIENT DENIED HEADACHES. THE POSTERIOR AND ANTERIOR INCISIONS WERE WITHOUT ERYTHEMA, SWELLING OR DRAINAGE AND WERE WELL APPROXIMATED. THE PATIENT OUTCOME WAS NOTED AS RESOLVED WITHOUT SEQUELA (B)(6) 2013. THE PUMP WAS USED TO DELIVER PRIALT. ADDITIONAL INFORMATION LATER CHANGED THE ETIOLOGY FROM INTRATHECAL SITE TO SURGERY/ANESTHESIA, RELATED TO IMPLANT PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
260082	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1	00033 YR		Required Intervention