FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 3252932 · Received July 29, 2013

Report

Report Number: 3004209178-2013-12443
Event Type: Injury
Date Received: July 29, 2013
Report Date: July 8, 2013
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8 596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8731, LOT# B005720N22, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE DRUG FROM THE CATHETER ACCESS PORT (CAP) DURING A CATHETER DYE STUDY AND SO THE CATHETER WAS REPLACED. THE TIMELINE OF THE CAP ISSUES WAS UNKNOWN. THE PATIENT¿S PERSONAL THERAPY MANAGER AND DAILY DOSES WERE DECREASED FOLLOWING THE REVISION. THE PUMP WAS INFUSING CLONIDINE, BUPIVACAINE, COMPOUNDED BACLOFEN, AND DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352143	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention