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

Model Number 8637-40

Device Problems Nonstandard Device (1420); Pumping Stopped (1503); Failure to Deliver (2338); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/29/2018

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 consumer regarding a patient receiving bupivacaine and dilaudid, dose and concentrations not reported via an implantable pump. The indications for use were non-malignant pain and chronic low back pain. On (b)(6) 2018 the patient reported that they had a refill last wednesday and today she tried to deliver a bolus and couldn¿t as she was seeing a code on the ptm (personal therapy manager); code 8476 (motor stall) and sees a bell on the ptm. The patient had heard the alarm and the agent played the pump alarms and the patient confirmed she was hearing the single tone beep (non-critical alarm). The alarm was heard on (b)(6) 2018. There were no patient symptoms reported and the patient was to follow up with their healthcare provider to have the pump/event logs checked to determine why the pump was alarming. No further complications were reported regarding the event.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4). 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 the consumer via the manufacturing representative 2018-aug-10. It was reported the patient was receiving 15 mg/ml of dilaudid at 4 mg/day. The patient reported the pump had alarmed because it reached end of service (eos). The pump was replaced on (b)(6) 2018. The issue had been resolved at the time of the report. The patient's status was provided as "alive - no injury. " other medications being taken at the time, patient weight, and medical history were not available.

• 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: 7734684
• MDR Text Key: 115942858
• Report Number: 3004209178-2018-17010
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/16/2012
• 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-0497-2013

Patient Treatment Data

Date Received: 07/31/2018 Patient Sequence Number: 1