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

Model Number 8637-20

Device Problems Premature Discharge of Battery (1057); Break (1069); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Irritation (1941); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8598a, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Product id: 8596sc, serial# (b)(4), implanted:(b)(6) 2017, product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was receiving bupivacaine, dilaudid, and another unknown medication via an implantable pump for malignant pain.The drug concentration and dose rates of the pump medications were unknown.It was reported that the patient was having her pump replaced on (b)(6) 2018 due to normal battery depletion.It was noted that it had almost been 5 years and the pump has a shelf life.It was further reported that a physician had laid the catheter on her sacroiliac (si) joint which had been giving her terrible sciatic nerve pain caused by the pump itself.It was further noted that the catheter was shattered so they had to implant a new catheter.It was indicated as having been unknown if the change in therapy/symptoms were sudden or gradual.The date of the event regarding the shattered catheter was unknown.The terrible sciatic nerve pain had occurred in (b)(6) 2018 (month and year known only).It was noted that the patient sees two physicians.No further patient 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): 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: 7747601
• MDR Text Key: 115954052
• Report Number: 3004209178-2018-17376
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 10/06/2012
• 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