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

Model Number 8637-20

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

Patient Problems Fall (1848); Fatigue (1849); Overdose (1988); Pain (1994); Loss of consciousness (2418)

Event Date 10/04/2010

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 consumer regarding a patient who was receiving an unknown drug at an unknown dose and concentration via an implantable pump for stenosis and non-malignant pain.It was reported that the patient had some bad reactions to the pump and oral medications she had taken.It was stated that the bad reactions were that the patient could barely stay awake and would fall.It was further stated that it seemed to be that she was overdosing.The patient ended up in the hospital several times and the doctor stated the patient had too much medication in her system.It was also stated that since the patient had the pump, it seemed like the patient had too much because she would pass out and would be found on the floor for "god knows how many hours".The patient was still in pain since implant.It was noted that the pump was "maybe" filled with morphine.The doctors had dialed down her pump medication every time by 10% so she was "pretty much" at nothing.It was noted that the patient was very old, frail, and may not make it through a surgery.No further complications were reported or anticipated.

• 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: 6817624
• MDR Text Key: 83532060
• Report Number: 3004209178-2017-18063
• 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: Other
• Type of Report: Initial
• Report Date: 08/24/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2011
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 08/24/2017
• Date Device Manufactured: 06/22/2010
• 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
• Patient Age: 80 YR