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

Model Number 8637-40

Device Problem Volume Accuracy Problem (1675)

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

Event Date 01/04/2018

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 health care provider (hcp) via a device manufacturer representative regarding a patient receiving an unknown drug at an unknown concentration and dose via an implantable infusion pump. The indication for use was noted to be spinal pain. It was reported volume discrepancies over the past 3 refills (dates unknown). Per the caller, the actual residual volumes were greater than the expected residual volumes by 3. 7ml, 5ml and "7mls more/underinfusion. " it was unknown if the patient had experienced any symptoms. No further complications were reported.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a manufacturer representative on 2018-jun-13. It was reported that the volume discrepancy was first noticed on (b)(6) 2018. It was noted that on (b)(6), the actual reservoir volume (arv) and expected reservoir volumes (erv) were "6. 5/3. 1ml" and the patient started to report increases in pain. The patient's weight was (b)(6) at that time. On (b)(6) the arv and erv were "6/2. 3ml" and the patient reported no relief from a 100mcg increase. No changes were made, and the patient's weight was (b)(6) at that time. On (b)(6) the arv and erv were "11/6. 1ml" and the patient experienced increased thoracic pain. The dose was increased by 100mcg and the patient's weight was (b)(6) at that time. On (b)(6), the arv and erv were "9/2. 2ml" and the patient experienced relief for a short period of time. The dose was increased by 100mcg and the patient's weight was (b)(6) at that time. The cause of the volume discrepancies was unknown, and a catheter dye study was being ordered. Further imaging and therapies were ordered but due to limited medical coverage, the patient was unable to "do. ".

• 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: 7591463
• MDR Text Key: 110869340
• Report Number: 3004209178-2018-13174
• 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

• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial