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

Model Number 8637-40

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 07/26/2017

Event Type  Injury  

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

Information was received from a healthcare provider regarding a patient who was receiving an unknown drug at an unknown concentration and dosage via an implantable pump for non-malignant pain.On 2017-oct-02, it was reported that the patient's pump had undergone premature eri.A non-critical alarm occurred and eri occurred was confirmed through telemetry.At the patient's last refill appointment on (b)(6) 2017, the eri was at 32 months.The pump was interrogated on (b)(4) 2017 and eri was shown to have occurred on (b)(6) 2017.No symptoms were reported.No further complications were reported.

Manufacturer Narrative

Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code because, although the device meets design specification, corrective actions are focused on enhancements to the design making this the closest code available with respect to this event.Analysis of the implantable infusion pump (serial # (b)(4)) revealed electrochemical migration across the electrical feed-through insulator which caused an electrical short.The electrical short resulted in a low battery reset/motor stall.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Interrogation of the pump found that it was delivering 20 mg/ml morphine at 3.495 mg/day and 340 mcg/ml clonidine at 59.42 mcg/day.If information is provided in the future, a supplemental report will be issued.

Event Description

The device was returned to the manufacturer.

Manufacturer Narrative

Updated to reflect the report that a pump replacement is pending.Updated to reflect the information received on (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on (b)(6) 2017 from the patient's healthcare provider (hcp).It was reported that the patient's pump was refilled as scheduled.The cause of the premature eri was not determined.A replacement was not scheduled, but was pending.It was confirmed that the pump would be returned to the manufacturer once it is explanted.The patient's weight was provided.The issue was not considered resolved as replacement was pending.No further complications were reported.

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 on (b)(6)2017 and would be sent back to the manufacturer for analysis.

• 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: 6914058
• MDR Text Key: 88157788
• Report Number: 3004209178-2017-20598
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 122