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

Model Number 8637-40

Device Problems Kinked (1339); Aspiration Issue (2883)

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

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

The other relevant components include: product id: 8780, serial# (b)(4) implanted: (b)(6) 2015, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer's representative regarding a patient who was receiving 500mcg/ml dilaudid at 24mcg/day via an implantable infusion pump for an unknown indication for use.It was reported that the patient's catheter was "non-working." it was reported that the hcp was unable to aspirate the catheter so the hcp decided to revise it.The hcp initially opened the back and cut the catheter and had great flow from the spinal segment.The hcp then used a collet to reconnect the catheter segments.The hcp then went into the pump pocket and mentioned there might have been a kink with the catheter.The hcp straightened out the catheter and was able to aspirate from the side port of the pump.It was reported the issue was resolved at the time of the report.The patient's status at the time of the report was noted as "alive-no injury." no further complications were anticipated/reported.

• 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: 7176017
• MDR Text Key: 96763851
• Report Number: 3004209178-2018-00477
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• 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: 01/04/2018
• Date Device Manufactured: 06/02/2015
• 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: 79 YR