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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

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

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: product id 8711, serial# (b)(4), product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8711, serial/lot #: (b)(4), ubd: 14-dec-2011, udi#: (b)(4).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 device manufacturer representative regarding a patient receiving morphine(60 mg/ml at 11.5 mg/day) via an implantable infusion pump.The indication for use was non-malignant pain.It was reported that the actual reservoir volume (arv) was greater than the expected reservoir volume (erv).The specific volumes of the arv and erv were unknown.The hcp performed a dye study and believed that the occluded catheter was cleared.The pump reservoir was checked and the volumes were accurate.There were no motor stall events in the pump logs.No symptoms were reported.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider indicated that the cause of the catheter occlusion was unable to be verified.No further complications have been reported as a result of this event.

Manufacturer Narrative

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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7645648
• MDR Text Key: 112869371
• Report Number: 3004209178-2018-14538
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 08/09/2017
• 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 Age: 60 YR