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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scar Tissue (2060); Weakness (2145); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 8709, serial# (b)(4), implanted: (b)(6) 2003, explanted: (b)(6) 2017, product type catheter.Product id 8578 , serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2017, product type catheter.

Event Description

Information was received from a patient who was receiving morphine (unknown) at an unknown concentration at minimum rate via intrathecal drug delivery pump for non-malignant pain and failed back surgery syndrome.It was reported that the patient wanted to know what crystallization in the catheter meant as that was what the doctors told him.The catheter had a lot of scar tissue because it was in the patient's body so long.The patient had been gradually losing the ability to walk or use his legs starting 3-4 years ago and had been getting weaker and weaker.They were going to replace the catheter due to crystallization which could be very dangerous and could potentially kill him.It was reported that removal of the pump and catheter had caused the loss of the ability to use his legs.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a health care professional indicated that the system was removed "for patient preference" and nothing was wrong with it.No further complications were reported.Mdr decision corrected to not reportable.No additional supplementals required unless additional information received indicates reportable event.

• 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: 7234112
• MDR Text Key: 98781681
• Report Number: 3004209178-2018-01823
• Device Sequence Number: 1
• Product Code: LKK
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2018

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: 09/28/2011
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/01/2018
• Supplement Dates Manufacturer Received: 01/29/2018; 02/13/2018
• Supplement Dates FDA Received: 02/01/2018; 02/14/2018
• Date Device Manufactured: 03/31/2010
• 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-1573-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention