SYNCHROMED II

MDR report key: 3941614 · Received July 17, 2014

Report

Report Number: 3004209178-2014-13177
Event Type: Injury
Date Received: July 17, 2014
Date of Event: June 26, 2014
Report Date: June 30, 2014
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

PRODUCT ID: 8781, LOT# N467180003, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DAY AFTER PUMP REPLACEMENT, THE PATIENT WAS LETHARGIC. TWO DAYS POST IMPLANT, THE PATIENT PRESENTED WITH MOTOR WEAKNESS, DROWSINESS, NAUSEA, DIZZINESS AND IRRITABILITY. THE EVENT RESULTED IN AN UNSCHEDULED OFFICE VISIT ON (B)(6) 2014 AND WAS NOTED TO BE RELATED TO THE INTRATHECAL MEDICATION; THE PATIENT WAS OVERMEDICATED. NO DEVICE DIAGNOSTICS WERE DONE. THE SEVERITY OF THE EVENT WAS NOTED TO BE ¿MILD¿. THE OUTCOME WAS REPORTED AS ¿ONGOING¿ AS OF (B)(6) 2014, IT WAS LATER REPORTED THAT THE EVENT WAS RELATED TO THE INTRATHECAL BACLOFEN AND HYDROMORPHONE. IT WAS LATER REPORTED THAT THE PUMP WAS REPROGRAMMED ON (B)(6) 2014; THE DOSAGE WAS HALVED. ON (B)(6) 2014, ANOTHER 30% IN THE DOSAGE WAS MADE.

Description of Event or Problem · 1

ADDITIONAL INFORMATION LATER REPORTED THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. ADDITIONAL INFORMATION LATER REPORTED THE CLINICAL DIAGNOSIS WAS MEDICATION SIDE EFFECTS. THE INTRATHECAL DAILY DOSE WAS DECREASED 50% ON (B)(6) 2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
419861	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MEDTRONIC PUERTO RICO OPERATIONS CO.	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1	00032 YR		Required Intervention