MAUDE Adverse Event Report: MEDTRONIC 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 Dyspnea (1816); Overdose (1988); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 11/01/2016

Event Type  Injury  

Event Description

Information was received from a patient who was receiving dilaudid (unknown concentration, dose 2.75 mg/day) via an implantable pump for spinal pain.Beginning (b)(6) 2016, the patient felt like he was getting too much medication from the pump, patient was having a hard time trying to breathe and he was trying to figure out if he could meet with a company representative to turn the pump down as his health care professional was in a different state.

Event Description

Additional information was received from a healthcare provider (hcp) on 2017-jan-11.It was reported that the patient's side effects were noted to have begun on (b)(6) 2016.The patient called the hcp on (b)(6) 2017 and complained of trouble breathing, pain at night, not feeling normal, and overdose symptoms.The hcp recommended going to the emergency room, but the patient declined.It was noted that the patient's pump medication was changed from morphine to dilaudid in either (b)(6) of 2016.The pump was to be checked and the programmed settings were to be verified.

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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6221763
• MDR Text Key: 63839974
• Report Number: 3004209178-2017-00164
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2017
• Date Device Manufactured: 12/23/2015
• 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: 60 YR