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

Model Number 8637-40

Device Problem Mechanical Jam (2983)

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

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed the pump was returned for analysis and upon device interrogation the pump was used to infuse baclofen 2,000.0 mcg/ml at 1,050.1 mcg/day if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via company representative regarding a patient receiving drug via an implantable pump.The drug being delivered via the device system was not reported.The indications for use were intractable spasticity and spinal cord injury/spinal cord disease.It was reported that on (b)(6) 2018 the company representative received a text from the healthcare provider who stated that the pump would have to be replaced due to a motor stall with no recovery.Per the company representative the patient had a mri of the spine on (b)(6) 2018.The pump had stalled and never recovered.The patient had an mri the same day as the motor stall according to the logs.The reporter was unsure of the time of the mri but knew that patient had an mri the same day the pump had stalled.The reporter also did not have the time that the motor stall occurred.The cause of the motor stall with no recovery was unknown/not determined and was why the pump was being sent back for analysis.Per the company representative the patient was having compliance issues and was not making the physician aware of when they were having multiple mris or when the mris were scheduled, so it was unknown if the motor stall was due to mri or not.Per the reporter all they knew is that the patient had an mri the same day as the motor stall.The reporter also stated that the patient stated that their pain was getting worse, but the pump was not implanted for pain.The pump was implanted for spasticity and the patient's spasticity was fine.The patient¿s weight was noted to be between (b)(6) no further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the pump revealed no significant anomaly; pump exterior impact dents, did not affect infusion.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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7592388
• MDR Text Key: 110783444
• Report Number: 3004209178-2018-13214
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 07/05/2018; 07/05/2018
• Supplement Dates FDA Received: 07/05/2018; 07/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 73