FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 2873887 · Received December 14, 2012

Report

Report Number: 3004209178-2012-11842
Event Type: Injury
Date Received: December 14, 2012
Report Date: November 14, 2012
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: UT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF THE CATHETER REVEALED CORING, TEARS, OR CUTS IN THE SEAL OF THE SUTURELSS CONNECTOR. DURING PRESSURE TESTING, A LEAK WAS SEEN FROM THE SUTURELESS CONNECTOR. RECENT FDA CODING CHANGES OFFER LIMITED OPTIONS FOR MEDICAL DEVICE EVALUATION CONCLUSION CODING.

Additional Manufacturer Narrative · 1

CATHETER MODEL 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: UNKNOWN. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT EXPERIENCED INCREASED SPASTICITY AND ITCHING, CAUSE NOT REPORTED. IT WAS ALSO NOTED THAT ON (B)(6) 2012 30 MCG BOLUS GIVEN THROUGH THE PUMP, WHICH RESULTED IN TONE DECREASED, ITCHING STILL PRESENT. ON (B)(6) 2012 DOSE INCREASE OCCURRED, NO PATIENT RESULTS NOTED. ON (B)(6) 2012 AN ORAL BACLOFEN TRIAL RESOLVED ITCHING AND AGITATION. A CATHETER REVISION OCCURRED ON (B)(6) 2012 FOR AN "UNKNOWN" CATHETER ISSUE. CATHETER WAS TO BE RETURNED. THE DEVICE SYSTEM WAS USED TO INFUSE BACLOFEN. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS NOTED AS ALIVE, NO INJURY/NO ADVERSE ADVENT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention