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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient receiving dilaudid 1.5 mg/ml for a total dose of 0.2999 mg/day and bupivacaine 30 mg/ml for a total dose of 5.997 mg/day via an implantable pump for non-malignant pain.It was reported on (b)(6) 2017 during a pump refill, device interrogation/device data revealed a pump reservoir volume discrepancy w here the interrogated reservoir volume (irv) was 20.8ml and the actual aspirated volume (aav) was 24ml.On (b)(6) 2018 during a pump refill, device interrogation/device data revealed a pump reservoir volume discrepancy where the irv was 18.9ml and the aav was 25ml.It was noted that no associated symptoms were reported.No further diagnostics were performed/no action was taken.The outcome of the event was unresolved with no further actions planned.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.The event date was (b)(6) 2017.No further complications were reported/anticipated.There was additional information reported that was not relevant to this event and therefore was omitted.

Manufacturer Narrative

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

Event Description

Additional information received from healthcare professional (hcp) via a clinical study indicated on (b)(6)2018 the patient presented for a pump adjustment secondary to increased lower back pain/worsening pain.A reservoir volume discrepancy was noted at their last refill on (b)(6)2018.The patient's volume was checked at this visit ((b)(6)2018) and device interrogation/device data revealed a 3ml volume discrepancy.It was noted that the patient will be scheduled for pump replacement.No action was currently taken.The outcome of the event was noted as ongoing.The clinical diagnosis was decreased therapeutic effect.The cause of the volume discrepancies was not determined.The patient's baseline weight was (b)(6)pounds.No further complications was reported/anticipated.

• 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: 7448159
• MDR Text Key: 106655618
• Report Number: 3004209178-2018-08518
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

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: 02/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 04/30/2018
• Supplement Dates FDA Received: 05/02/2018
• Date Device Manufactured: 08/15/2013
• 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: 39 YR
• Patient Weight: 83