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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Pumping Stopped (1503); Mechanical Jam (2983)

Patient Problems Itching Sensation (1943); No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2017

Event Type  malfunction  

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

Information was received from a healthcare provider (hcp) regarding a patient who was receiving 2000 mcg/ml lioresal at a dose of 180.5 mcg/day via an implantable pump for intractable spasticity and multiple sclerosis.It was reported that the patient had an mri on (b)(6) 2017, but was not able to get the pump checked until (b)(6) 2017.The hcp interrogated the pump with logs about 8 times, one interrogation after another, and had not seen the motor stall recovery occur.The hcp tried using another physician programmer to interrogate, but had still not seen a recovery.The pump logs showed that the motor stall occurred on (b)(6) 2017 at 14:08 and tube set error occurred on (b)(6)2017.They heard the pump alarm on (b)(6) 2017.Prior to (b)(6) 2017, the patient had not heard any alarms from the pump.At the time of the call, it had been about 20 minutes since the last interrogation of the pump.The hcp went to interrogate the pump again and confirmed she was still not seeing the motor stall recovery occur.The hcp tried using another programmer and got the same thing.The patient heard the alarm again as well.The patient had not had any change in symptoms.The patient did complain about ongoing itching, but she had been complaining about that for a while (prior to the mri on (b)(6) 2017).The itching had not gotten worse.There were no further complications reported or anticipated.

Manufacturer Narrative

(b)(4) no longer applies.(b)(4) no longer apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) on (b)(6) 2017.The actions/interventions taken to resolve the motor stall following mri was interrogation of the pump several times.The motor stall had been resolved/recovered on (b)(6) 2017 at 10:18.The patient¿s weight at the time of the event was unknown.It was stated that the ongoing itching was not related.The cause of the ongoing itching was stated that the patient had a history of itching.There had been no change in the patient's itching.

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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6591861
• MDR Text Key: 76035647
• Report Number: 3004209178-2017-11074
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2017
• Date Device Manufactured: 07/31/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0592-2009
• Patient Sequence Number: 1
• Patient Age: 48 YR