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

Model Number 8637-40

Device Problems Premature End-of-Life Indicator (1480); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

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

Event Date 12/30/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8840, serial# unknown, product type: programmer, physician.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer's representative regarding a patient who was receiving baclofen, clonidine, and dilaudid via an implantable pump for non-malignant pain and failed back surgery syndrome.The concentrations and doses of the drugs were unknown.It was reported on (b)(6) 2017 that an alarm was heard but telemetry was not yet performed as no clinician programmer was available.It was related that the patient called the manufacturer's representative and the alarm was occurring every 40 minutes.The patient did not have a personal therapy manager (ptm) and the alarm was unknown.There were no known symptoms.The date of the event was (b)(6) 2017.No further complications were reported or anticipated.Additional information was received from the manufacturer¿s representative (rep) on 2018-jan-25.The most appropriate follow up cont act was provided.It was reported that the pump was replaced as an action taken to resolve the alarm.The cause of the alarm was reported as end of service (eos).The alarm was resolved.The patient¿s weight at the time of the event was unknown.

Manufacturer Narrative

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

Event Description

Additional information was received via a healthcare provider.It was indicated that the serial number of the clinician programmer used was unable to be obtained.Regarding the cause of end of service (eos), the critical pump alarm was sounding on (b)(6) 2017 and elective replacement indicator (eri) was reported as having been 7 months; high concentration and polypharmacy was further indicated.Premature end of service (eos) was reported.Regarding the current status of the pump, it was noted that it had been disposed of as medical waste at the time of surgery.

Manufacturer Narrative

Concomitant medical products: product id 8870, lot# unknown, serial# unknown, product type software.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
• MDR Report Key: 7229069
• MDR Text Key: 98603974
• Report Number: 3004209178-2018-01688
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR