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

Model Number 8637-40

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

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 professional (hcp) regarding a patient receiving unknown baclofen via an implantable infusion pump for intractable spasticity and cerebral palsy.It was reported that the patient came in to the emergency room (er) on (b)(6) 2017 because they saw elective replacement indicator (eri) but did not know what it meant.It was not clear how the patient saw this message as the hcp did not have any details.The eri appeared to be early based on the previous value of 15 months according to the patient's parents.An alarm was heard and eri was confirmed via telemetry.No symptoms were reported.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the patient had surgery to replace the pump on (b)(6) 2017.The cause of the early elective replacement indicator (eri) was not determined.The early eri had not been resolved.No additional complications were expected or 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): 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: 6681874
• MDR Text Key: 78980794
• Report Number: 3004209178-2017-14086
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2017
• Date Device Manufactured: 05/27/2011
• 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
• Patient Age: 28 YR
• Patient Weight: 45