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 07/13/2017

Event Type  Injury  

Event Description

Information was received from a healthcare provider via a manufacturer representative on (b)(6) 2017 regarding a patient receiving compounded baclofen (1100mcg/ml at 174.8mcg/day) via an implanted infusion pump.The indications for use included intractable spasticity and spinal cord injury/spinal cord disease.It was reported that the elective replacement indicator (eri) was occurring unexpectedly.The alarm was heard and confirmed by telemetry, and it was noted that the eri was premature.The event date was noted to be (b)(6) 2017.It was noted that the alarm was not silenced but it should be fine since the patient could barely hear it.The pump was reportedly still infusing as of the date of report.No patient symptoms were reported, and it was noted that they had a potential date to replace the pump on (b)(6) 2017.No further complications were reported or anticipated.

Manufacturer Narrative

Interrogation of the device revealed the pump had been programmed to deliver 1,150.0 mcg/ml of baclofen at 174.8 mcg/day.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

The pump and catheter were returned to the manufacturer for analysis.It was indicated the reservoir was empty because the drug was transferred to the replacement pump at surgery on (b)(6) 2017.

Manufacturer Narrative

The pump was returned for analysis.During decontamination in the lab, a low battery reset occurred.Destructive analysis identified a high battery resistance during functional testing.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: 7109638
• MDR Text Key: 94557681
• Report Number: 3004209178-2017-25861
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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-2276-2009, Z-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 77