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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2018, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 30-oct-2009, udi#:(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving gablofen (500 mcg/ml, 100 mcg/day) via intrathecal drug delivery pump for intractable spasticity and spinal cord injury/spinal cord disease.It was reported that the patient had an abrupt onset of loss of therapy and despite dosing increases the symptoms persisted."1 week ago" the hcp attempted a dye study and was unable to aspirate from the catheter access port."today" they did a catheter replacement.The pump was refilled in the operating room "today" and the expected residual volume was 17.5 ml while the actual residual volume was 35 ml.The catheter was occluded.The rep required assistance related to programming a priming bolus.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional.It was reported that it was unknown whether the catheter would be returned to the manufacturer for analysis.The patient's symptoms were resolved.The patient's weight at the time of the event was unknown.No further complications were reported.

• 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: 7504687
• MDR Text Key: 107956693
• Report Number: 3004209178-2018-10640
• 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
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Date Device Manufactured: 09/26/2014
• 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