FDA Adverse Event Death Summary report: N

SYNCHROMED II

MDR report key: 3080146 · Received April 26, 2013

Report

Report Number: 3004209178-2013-06942
Event Type: Death
Date Received: April 26, 2013
Report Date: March 30, 2013
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID: 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4). DATE OF DEATH WAS NOT PROVIDED, DATE IS APPROXIMATE.

Description of Event or Problem · 1

IT WAS INITIALLY REPORTED THAT THE PATIENT PASSED AWAY AND IT WAS UNRELATED TO THE DEVICE OR THERAPY. IT WAS ADDED THAT THE CAUSE WAS RELATED TO A PRE-EXISTING CONDITION, WORSENING OR EXACERBATION. THE PATIENT WAS PARALYZED FROM THE LOWER STERNUM DOWN; SHE HAD THE DIAGNOSES OF MS AND STILL'S DISEASE AND SHE HAD A LONG BATTLE WITH DECUBITI/INFECTIONS/ETC. THERE WERE NO ACTIONS TAKEN AND NO DIAGNOSTICS PERFORMED. THE PUMP SYSTEM WAS DELIVERING HYDROMORPHONE, BUPIVACAINE, AND BACLOFEN. IT WAS LATER REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN AND THAT THE PATIENT HAD MULTIPLE COMORBIDITIES INCLUDING: MORBID OBESITY, MS, STILL'S DISEASE, QUADRIPLEGIA, DECUBITI, AND INFECTIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
182926	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1	00053 YR		Death