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 Low Blood Pressure/ Hypotension (1914); Weakness (2145); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 10/01/2015

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 dilaudid (hydromorphone) (2.0 mg/ml at 0.8579 mg/day) and bupivacaine (1.0 mg/ml at 0.4289 mg/day) via an implantable pump for non-malignant pain and failed back surgery syndrome.An examination of the patient was performed on (b)(6) 2015.The patient became shaky, weak, and unresponsive when called to the room.Emergency medical services (ems) was contacted to take the subject to the hospital, but the patient refused.This intervention was noted as medical or non-surgical therapy.The event resulted in an unscheduled clinic or office visit.The clinical diagnosis was a hypotensive episode.The event was possibly related to the device/therapy.The event was not related to the implant procedure.Other etiology included cardiac comorbidities.The event resolved without sequelae on (b)(6) 2015.Additional information was received.The clinical diagnosis was updated to hypotensive episode at pump fill appointment.The etiology was updated.The event was possibly related to the drug (hydromorphone).There was no change in the drug that caused the event.No further complications were anticipated.

Event Description

Additional information received from a healthcare provider via a clinical study reported the etiology was possibly related to the in trathecal drug hydromorphone with the drug action that caused the event being no change in drug.No further complications anticipated.

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: 6380262
• MDR Text Key: 69146518
• Report Number: 3004209178-2017-05059
• 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,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• 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: 03/28/2017
• Date Device Manufactured: 10/30/2013
• 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): Required Intervention
• Patient Age: 89 YR