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

Model Number 8637-20

Device Problems Premature End-of-Life Indicator (1480); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8598a, serial (b)(4), product type: catheter.Product id: 8709sc, serial (b)(4), product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8598a, serial/lot (b)(4), ubd: 25-apr-2019, (b)(4); product id: 8709sc, serial/lot (b)(4), ubd: 04-mar-2015, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving fentanyl and clonidine at unknown concentration and doses via an implantable infusion pump.The indications for use were noted to be non-malignant pain and failed back surgery syndrome.It was reported that the patient's pump died early and she got an infection.The patient stated she went into the office on (b)(6) 2018 and said something was wrong and the doctor told her she was in withdrawal and the pump was dead.According to the pump print out the pump had 15 months left.She said she saw an alert showed up on (b)(6) 2018.On (b)(6) 2018 "they had no choice" but to remove her pump and catheter.She stated she was still going through withdrawals from when the pump died.She had only been given "a so many day supply of higher opioid to take before they put in another pump." she also stated there was a "big gaping hole" where the pump was and she had cellulitis in the pump.It was noted the patient had been dismissed by her managing physician and she was provided with listings for other doctors.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that a new pump had not been placed "yet" due to the hole that was there after the pump was removed.The hole "was stitches" and new growth had to grow.The healthcare professional was cutting below the pump.The patient was put on antibiotics.The right side of the patient's stomach was pink.The cellulitis was all on the right side where the pump was placed.This occurred in either (b)(6) 2018 or (b)(6) 2018.No further complications were reported.

• 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: 7373185
• MDR Text Key: 103548613
• Report Number: 3004209178-2018-05796
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2018
• Date Device Manufactured: 08/29/2012
• 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
• Patient Age: 66 YR