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

Model Number 8637-40

Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

Patient Problems Therapeutic Response, Decreased (2271); Weight Changes (2607)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional (hcp).It was reported that because the pump battery died (clarified as referring to the low battery reset), the hcp elected not to refill or replace the pump.However, because the patient's family wasn't returning calls, the patient ran out of medication for 2 weeks.Per the hcp, the patient's weight wasn't available as they weren't able to weigh her, but she had lost a lot of weight.No further complications were reported.

Manufacturer Narrative

Date of event is an estimate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was receiving bupivacaine (5 mg/ml, 1.99 mg/day) and morphine (50 mg/ml, 19.99 mg/day) via intrathecal drug delivery pump for non-malignant pain and failed back surgery syndrome.It was reported that the patient had been without medication for over 2 weeks as the pump was not refilled.The pump was interrogated and noted to be in safe state.The low reservoir and empty pump alarms occurred, as well as low battery reset and safe state.The pump logs were checked.The hcp asked to program the pump off permanently and successfully programmed the pump off.The patient's withdrawal was over and the patient was appearing comfortable.The pump was refilled about every 3 months and the reset happened after the most recent refill.The empty pump occurred "about 2 weeks ago." no further complications were reported. .

• 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: 7465521
• MDR Text Key: 106696489
• Report Number: 3004209178-2018-09380
• 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: health professional
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Date Device Manufactured: 04/19/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-3043-2011
• Patient Sequence Number: 1
• Patient Age: 100 YR