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

Model Number 8637-20

Device Problems Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Appropriate Term/Code Not Available (3191)

Patient Problem Underdose (2542)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

The other relevant components include: product id: 8840, serial# unknown, product type: programmer, physician.

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer¿s representative regarding a patient who was receiving morphine (36 mg/ml at 15 mg/day) and clonidine (200 mcg/ml at 83.3 mcg/day) via an implantable pump for an unknown indication for use.It was reported that an early elective replacement indicator (eri) and end of service (eos) occurred.The patient went in for a refill on (b)(6) 2017, and the eri was at 9 months.On (b)(6) 2017, the patient heard an audible alarm.On (b)(6) 2017, the alarm was still occurring.The patient experienced underdose symptoms, and contacted their physician.Telemetry was performed, revealing the pump had reached eri on (b)(6) 2017, and eos on (b)(6) 2017.The pump was switched off to silence the alarm.The patient was provided oral medication to avoid further underdose symptoms.Surgical intervention did not occur, and it was unknown if it was planned.There were no environmental, external, or patient factors that may have led or contributed to the issue.The issue was not resolved.The patient status was alive ¿ no injury.No further complications were reported.Pump logs were received from telemetry occurring on (b)(6) 2017.The eri occurred on (b)(6) 2017 at 03:42, and the eos occurred on (b)(6) 2017 at 05:42.The pump replace by date in the logs was shown as (b)(6) 2017.The eri was still at 9 months.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative indicated replacement was discussed with the patient, no surgery was still not scheduled.The surgery was expected within the next 6 weeks.The pump would be returned for analysis upon explant.As of (b)(6) 2017, the patient was still supplemented with oral medication.No further information was available.No further complications were reported/anticipated.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6481796
• MDR Text Key: 72452563
• Report Number: 3004209178-2017-08042
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Date Device Manufactured: 01/20/2011
• 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: 63 YR