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

Model Number 8637-20

Event Date 01/01/2017

Event Type  Injury  

Event Description

Information was received from a manufacturer's representative regarding a patient who was receiving dilaudid (concentration of 12mg/ml, dose unknown) via an implantable infusion pump for non-malignant pain.It was reported on (b)(6) 2017 that the patient was supposed to be refilled sometime after (b)(6) but the patient had moved and was currently in hospice.It was assumed that the alarm is due to a low or empty reservoir, but the patient/family had decided that weren't going to worry about getting the pump refilled.It was stated they wanted it programmed off entirely.It was stated that the patient was being taken care of by hospice with medications so they were not going through withdrawal.A rep called requesting the pump off password and confirmed they were able to program the pump to the pump off state.It was them stated the patient came in at 7:30am with signs of withdrawal.It was stated they tried to program the pump to simple continuous mode and it kept going to safe state.It was stated the pump was being replaced on the following monday and returned to the manufacturer for testing.

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: 6330695
• MDR Text Key: 67437368
• Report Number: 3004209178-2017-03879
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: 01/19/2017
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 09/24/2012
• 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: 54 YR