FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 3912724 · Received July 3, 2014

Report

Report Number: 3004209178-2014-12497
Event Type: Injury
Date Received: July 3, 2014
Report Date: June 5, 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: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8780, SERIAL# (B)(4). IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem · 1

POST-OPERATIVE URINARY RETENTION AND DIFFICULTY VOIDING WAS OBSERVED ON (B)(6) 2014. THIS RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION. THE PATIENT¿S MEDICATION WAS ADJUSTED IN GIVING THE PATIENT ORAL FLOMAX. AN 88% REDUCTION IN DOSE ON (B)(6) 2013 WAS ALSO OBSERVED IN THE LOGS, THOUGH IT WAS UNCLEAR IF THIS WAS PERFORMED IN RELATION TO THE PATIENT¿S RETENTION. THE PATIENT WAS VOIDING NORMALLY ON (B)(6) 2013. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. THE MEDICATION INFUSED WAS MORPHINE. ETIOLOGY SPECIFIED THE EVENT WAS UNLIKELY RELATED TO THE DEVICE OR THERAPY AND WAS RELATED TO THE IMPLANT PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
389165	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1	00056 YR		Hospitalization