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

Model Number 8637-40

Device Problem Failure To Service (1563)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a manufacturer representative on (b)(6) 2018 regarding a patient receiving unknown medi cation (dose and concentration unknown) via an implanted infusion pump.The indications for use included non-malignant pain and failed back surgery syndrome.It was noted that prior to pump implant, about six months after the patient got back surgery in late 2002/early 2003, the patient was on fentanyl patches and ran out of patches.The patient went through complete withdrawal for two days and the healthcare provider (hcp) had to (b)(6) fentanyl overnight.It was reported that the patient was supposed to be filled on monday (relative to the date of report), but was not filled because the doctor was found dead.The patient called around and couldn't find a doctor to fill the pump.Per a manufacturer representative, a new hcp agreed to take the patient, and the patient was calling the office on (b)(6) 2018.No patient symptoms were reported and no further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative on (b)(6) 2018.It was indicated the patient had been referred to a new managing physician.However, it was unknown if the missed refill issue had been resolved at the time of the report.The patient's weight was unknown.

• 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: 7652902
• MDR Text Key: 112850246
• Report Number: 3004209178-2018-14730
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2018
• Date Device Manufactured: 06/28/2012
• 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 Age: 57 YR