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

Model Number 8637-20

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problems Fall (1848); Muscle Spasm(s) (1966); Pain (1994)

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving lioresal (500 mcg/ml at 59.92 mcg/day) via an implantable infusion pump for intractable spasticity and multiple sclerosis.It was reported that a volume discrepancy was noted on (b)(6) 2018.The actual residual volume (arv) was 19 while the expected residual volume was 1.6.The patient had a couple of falls, spasms, and pain.Previously, the pump was filled on 2017-sep-06, and there was no discrepancy at that time.No further complications were reported.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the hcp indicating that a catheter dye study was done on 2018-feb-14, which indicated a blocked catheter.The hcp was unable to draw any fluid out of the catheter access port (cap).The hcp tried to push contrast dye through the port, but was not able to push any fluid through the port and met high resistance.The volume discrepancy was not resolved, and it was noted that the pump required another revision and catheter assessment.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Patient code (b)(4) was removed because it no longer applied.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received, indicating that the patient experienced increased spasms and increased pain since the beginning of (b)(6)2018.

• 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: 7251691
• MDR Text Key: 99897209
• Report Number: 3004209178-2018-02337
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2018
• Date Device Manufactured: 01/12/2016
• 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: 54 YR
• Patient Weight: 112