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); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant product(s): product id: 8711, serial# (b)(4), implanted: (b)(6) 2007, product type: catheter.Product id: 8711, lot# j10874r19, implanted: (b)(6) 2001, product type: catheter.Product id: 8596, serial# (b)(4), implanted: (b)(6) 2007, product type: catheter.Product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter.Other relevant device(s) are: product id: 8711, serial/lot #: (b)(4), ubd: 04-oct-2008, udi#:(b)(4); product id: 8711, serial/lot #: (b)(4), ubd: 31-jul-2003, udi#: (b)(4); product id: 8596, serial/lot #: (b)(4), ubd: 29-nov-2008, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: 01-jul-2015, 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) regarding a patient receiving bupivacaine (5 mg/ml at an unknown dose) and dilaudid (1 mg/ml at an unknown dose) via an implanted pump.The indication for pump use was failed back surgery syndrome, non-malignant pain, and spinal pain.On (b)(6) 2018 it was reported that it was confirmed that the catheter was occluded.A dye study and imaging (mri, ct scan) had been done.They could not aspirate from the cap (catheter access port) at the dye study.There was also a volume discrepancy where the reporter almost got back a full reservoir of drug.They were not sure if the catheter was occluded due to a granuloma (inflammatory mass) or if the catheter was blocked for another reason.An mri was performed, but the reporter had limited details.The patient had been ¿getting worse and not getting good therapy¿ beginning earlier this year.The reporter had purposefully programmed the pump to stopped pump mode and the stopped pump alarm was sounding at the time of the report.Silencing the alarm and other options were reviewed.No further complications have been reported as a result of this 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: 7406152
• MDR Text Key: 105373808
• Report Number: 3004209178-2018-06717
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/09/2018

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: 02/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/09/2018
• Date Device Manufactured: 09/09/2013
• 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: 52 YR