MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 863720

Device Problems Improper or Incorrect Procedure or Method (2017); Overfill (2404)

Patient Problems Vomiting (2144); Complaint, Ill-Defined (2331)

Event Date 08/03/2004

Event Type  Injury  

Manufacturer Narrative

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 morphine at an unknown dose and concentration via an implantable infusion pump.The indication for use was spinal pain.It was reported that right after a pump implant surgery in (b)(6) 2004 the patient thinks the healthcare provider (hcp) put too much drug in the pump causing them to vomit and "everything else".It was noted that because the patient was diabetic he ended up having to be in the intensive care unit.No further complications have been reported as a result of this event.

Manufacturer Narrative

After further review of the event and source information the previous reported device code is no longer relevant.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): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7876725
• MDR Text Key: 120275247
• Report Number: 3007566237-2018-02748
• Device Sequence Number: 1
• Product Code: LKK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2006
• Device Model Number: 863720
• Device Catalogue Number: 863720
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2018
• Date Device Manufactured: 07/26/2004
• 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; Life Threatening
• Patient Age: 48 YR