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

Model Number 8637-20

Device Problems Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015)

Patient Problems Thrombosis (2100); Therapeutic Response, Decreased (2271)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a device manufacturer representative and a healthcare provider (hcp) regarding a patient who was receiving morphine (25 mg/ml at an unknown dosage) via an implantable infusion pump for non-malignant pain and failed back syndrome - other.It was reported that a critical pump alarm occurred on (b)(6) 2018 and was confirmed by telemetry.The patient presented to the emergency room (er) on (b)(6) 2018.The logs showed multiple resets, low battery resets, and safe state logs.The patient was experiencing withdrawal.It was unknown if there were any environmental/external/patient factors that may have contributed to the patient's withdrawal.The issue was not resolved at the time of the report.It was asked but unknown if surgical intervention had occurred.The patient's status at the time of the report was alive - no injury.It was further reported that the pump was non-functioning and the patient's scan was for the lumbar spine to rule out a potential abscess.No further complications were reported.

Manufacturer Narrative

(b)(4) does not apply to this event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer's representative (rep).It was reported that the pump was replaced.The patient was receiving 25mg/ml morphine at 3mg/day.No further complications were anticipated/reported.

Manufacturer Narrative

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

Manufacturer Narrative

Date for follow up number 004 was 2018-12-19.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer indicated that the patient experienced a blood clot due to the trouble with his pump.No further complications have been reported as a result of this event.

• 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: 7510975
• MDR Text Key: 108248440
• Report Number: 3004209178-2018-10807
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/02/2019

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: 12/14/2012
• 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: 05/10/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 05/23/2018; 07/18/2018; 08/08/2018; 08/08/2018; 12/19/2018
• Supplement Dates FDA Received: 05/23/2018; 08/08/2018; 10/04/2018; 12/20/2018; 01/02/2019
• Date Device Manufactured: 06/16/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR