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); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fatigue (1849); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type: catheter; product id: 8840, serial# unknown, product type: programmer, physician.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), (b)(6), (b)(4); product id: 8840, serial/lot #: unknown, (b)(6).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 who was receiving baclofen 1200 mcg/ml; 90 to 60 mcg/day and dilaudid 20 mg/ml; 5.1 to 1.5 to 0.991 mg/day via an implantable pump.Indication for use was non-malignant pain and failed back syndrome.The date of the event was approximately (b)(6) 2018.It was reported the catheter was determined to be occluded when a catheter dye study/myelogram was done (b)(6) 2018.The daily dose of the dilaudid was decreased/cut in half due to the pump and catheter being replaced today ((b)(6) 2018).The patient was very drowsy today ((b)(6) 2018) due to the anesthesia/other drugs on board so they decreased the intrathecal dose again.The hcp noticed a bridge bolus was also in progress.A programming error occurred related to the drug.Baclofen was accidently deleted as the secondary drug today ((b)(6) 2018) when it was not supposed to be as physically no drug/concentration changes were made at the pump and catheter replacement.No further complications were reported.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp).The patient experienced increased pain and poorly controlled pain symptoms.There was no specific cause of the catheter occlusion aside from the age of the pump.It was over 5 years old and due to be replaced.The patient drowsiness was not associated with the pump.Extra precaution was taken by lowering the initial dose of medication programmed so it would not contribute to drowsiness from anesthesia.The patient recovered the same day and was kept overnight to monitor respiratory status and signs and symptoms of withdrawal.The patient went home the next day following the procedure.The patient¿s weight at the time of the event was(b)(6) pounds.Medical history was chronic intractable severe low back pain.

• 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: 7528051
• MDR Text Key: 108723826
• Report Number: 3004209178-2018-11339
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: 03/14/2014
• 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: 05/03/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 05/22/2018
• Date Device Manufactured: 09/19/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 113