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

Model Number 8637-20

Device Problems Disconnection (1171); Material Separation (1562); Suction Problem (2170); Infusion or Flow Problem (2964); No Flow (2991)

Patient Problems Pain (1994); Malaise (2359); No Information (3190)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2011, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 26-aug-2012, udi#: (b)(4).(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving dilaudid (25 mg/ml at 6.9 mg/day) via an implantable infusion pump.The indication for use was noted to be non-malignant pain.It was reported that in (b)(6) 2017 the patient was not feeling pain relief and having extra pain.She didn't feel well with the pump.A ct scan/dye study was performed and it showed the "catheter separated." they could not aspirate the catheter, could not pull back any fluid and there was no flow.The catheter was replaced on (b)(6) 2017.No further complications were reported.

Manufacturer Narrative

Corrected information.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: 7744706
• MDR Text Key: 115894688
• Report Number: 3004209178-2018-17282
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2016
• 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: 01/16/2015
• 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: 52 YR