MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Decrease in Pressure (1490); Pumping Stopped (1503); Application Program Problem (2880)

Patient Problems Overdose (1988); Underdose (2542)

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

On 2017-mar-31, information was received from a foreign patient and healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was receiving lioresal (2000 ug/ml at a dose of 104.5 ug/day) via an implantable pump for an unknown indication for use.On an unknown date, the patient reported that during their vacation when they got on the plane, they felt symptoms of "infraposes".When the patient returned to their country and got off the plane, they felt symptoms of "overdoses".There were no known environmental/external/patient factors.A catheter and rotor test was performed.The catheter seemed permeable and the rotor marks did not show any movement at all.Logs were received and no events of a motor stall were recorded.No interventions occurred, but the patient was taking oral baclofen.The event was not resolved at the time of this report.Surgical intervention was planned, but not yet scheduled.The patient's status was listed as "alive - no injury".

Manufacturer Narrative

Device code (b)(4) was updated to (b)(4).

Event Description

Additional information received from a manufacturer representative indicated the symptoms of infradosis began when getting off the plane during vacation.The catheter and rotor test were performed on (b)(6) 2017.When the catheter and rotor studies were done in the quirofano (operating room), "rotation of the same one was not visualized." the cause of infradosis and overdose were not determined.The replacement of both the pump and catheter were completed on (b)(6) 2017.The patient was well and receiving therapy.Device return was expected, but no estimated date was provided.There were no further complications reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6454872
• MDR Text Key: 71551079
• Report Number: 3004209178-2017-06910
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Date Device Manufactured: 05/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention