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

Model Number 8637-40

Device Problems Kinked (1339); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

References the main component of the device system the relevant components include: product id: 8781, serial# (b)(4), implanted: (b)(6) 2017, 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 (rep) regarding a patient receiving 16 mg/ml morphine at a dose of 0.99 mg/day via an implantable infusion pump for spinal pain.It was reported that the patient had a lack of therapy.The hcp reported pulling out 38 cc at last refill in (b)(6) 2018.The pump said 3 cc in pump and the hcp pulled out 38.An environmental/external/patient factors that may have led or contributed to the issue was that the patient's pump flipped.A catheter and dye study was performed on (b)(6) 2018.The hcp was unable to aspirate from the access port as well as push dye.As an action/intervention taken to resolve the issue, the patient was sent to the surgeon for catheter replacement.The issue was not resolved at the time of this report.Surgical intervention was planned, after diagnostic catheter and dye study it was suspected that the catheter was kinked.The hcp was to be sending a referral to a surgeon for a revision.The patient's status was "alive - no injury" and no further complications were expected or anticipated.

• 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: 7303820
• MDR Text Key: 101237566
• Report Number: 3004209178-2018-04195
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• 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: 02/27/2018
• Date Device Manufactured: 04/21/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 78