SYNCHROMED II

MDR report key: 3964250 · Received July 29, 2014

Report

Report Number: 3004209178-2014-13626
Event Type: Injury
Date Received: July 29, 2014
Date of Event: July 9, 2014
Report Date: July 9, 2014
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: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4)

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED, THERE WAS A VOLUME DISCREPANCY. THE ACTUAL RESERVOIR VOLUME (35 ML) WAS GREATER THAN THE EXPECTED RESERVOIR VOLUME (5.6 ML). THE CAUSE OF THE DISCREPANCY WAS POSSIBLY DUE TO A CATHETER OCCLUSION. THEY CHECKED LOGS, PERFORMED AN X-RAY AND ATTEMPTED TO ASPIRATE FROM THE SIDE PORT AND WAS UNSUCCESSFUL. THE PATIENT HAD INCREASED SPASTICITY. THE PUMP WAS USED TO DELIVER LIORESAL (BACLOFEN). THE PATIENT WAS REFERRED TO ANOTHER HEALTHCARE PROFESSIONAL (HCP) FOR FURTHER INVESTIGATION.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S SYMPTOM WAS POOR TONE CONTROL OVER PAST FEW MONTHS. IT WAS NOTED THE VOLUME DISCREPANCY WAS DUE TO A CATHETER ISSUE WITH HIGH RESIDUALS THAT WERE NOTED BY THE MANAGING HCP. THE PATIENT WAS TAKEN TO THE OR (OPERATING ROOM) LAST WEEK AND A KINK IN THE CATHETER WAS FOUND THAT WAS JUST PROXIMAL TO THE ANCHOR. THE SECTION WAS SPLICED/REPAIRED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
441839	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1	00034 YR