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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Overdose (1988); Dizziness (2194); Sedation (2368); Cognitive Changes (2551)

Event Date 02/14/2014

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient who was receiving bupivacaine (30.0 mg/ml at 15.002 mg/day), dilaudid (5.0 mg/ml at 2.5003 mg/day), clonidine (300.0 mcg/ml at 150.02 mcg/day), and baclofen (150.0 mcg/ml at 75.01 mcg/day) via an implantable pump for malignant pain.While the patient was admitted for pneumonia, they became over-medicated.This was observed on (b)(6) 2014.The clinical diagnosis was intrathecal medication side effects.Narcan was administered, the fentanyl patch was discontinued, and oral opiates were held on (b)(6) 2014.Therapy was suspended by placing a magnet over the pump the same day.The next day, once the patient was aroused, therapy was resumed by removing the magnet.On (b)(6) 2014, sedation was observed and the intrathecal rate was decreased.On (b)(6) 2014, slight grogginess and dizziness were observed and the intrathecal rate was decreased again.Dizziness and sedation were observed on (b)(6) 2014, and the patient was instructed to drink caffeine for the dizziness.The event was not related to the implant procedure, but was related to the device/therapy.The drug action that caused the event was noted as an increase in the hydromorophone dose as well as the addition of baclofen and clonidine.The hydromorphone dose was increased from 1.50505 mg/day to 2.5003 mg/day.The event resolved without sequelae on (b)(6) 2014.The patient status is noted as deceased; this was investigated in another event and was determined to be unrelated to the product/therapy.

Manufacturer Narrative

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

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6283531
• MDR Text Key: 65961810
• Report Number: 3004209178-2017-01935
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• 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: 01/03/2017
• Date Device Manufactured: 12/02/2013
• 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 Outcome(s): Other
• Patient Age: 63 YR