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

Model Number 8637-40

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Muscle Spasm(s) (1966); Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 02/28/2016

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 consumer and a manufacturing representative regarding a patient receiving intrathecal baclofen via an implantable infusion pump for intractable spasticity and cerebral palsy.The dose and concentration were unknown.It was reported that as of (b)(6) 2016, the patient had been sick for three days.However, when asked if the date was (b)(6) 2016, the reporter confirmed ¿yes, but he was venturing a guess¿.The patient complained of a stomach ache, and they thought it was the stomach virus.That seemed to get better, but then the patient had congestion.¿muscle convulsions¿ were noted.Every now and then, the patient ¿winced like in sharp pain¿.The patient was afraid the pump was failing.The patient was currently at home, and [their friend/family member] was hesitant to take the patient out and go to the hospital.The patient¿s pump was checked.There were no active alarms, and there was nothing in the pump logs that would suggest a pump issue.The representative explained to the consumer that there still could have been an issue with the rest of the system, but that the patient would need to be seen by his physician for the pump to look f urther into it.The patient¿s primary care physician was to see the patient on the evening of (b)(6) 2016.No interventions were mentioned.There were no further complications reported.

• 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: 6768230
• MDR Text Key: 81852027
• Report Number: 3004209178-2017-16273
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2016
• Date Device Manufactured: 10/15/2013
• 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 Age: 29 YR