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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Aspiration Issue (2883); Infusion or Flow Problem (2964)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2009, product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: (b)(6) 2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a consumer (friend/family member) regarding an implantable intrathecal pump intended to deliver dilaudid (at unknown concentration and dose), indicated for non-malignant pain and failed back surgery syndrome.It was reported that there was an issue with the patient¿s catheter.It was reported that they discovered that the catheter was blocked in (b)(6) 2018.Per the caller, "within the past two weeks, maybe (b)(6) 2018" but they weren't sure.A dye test was done which failed.It was stated that the dye test was done because the patient was not feeling the boluses.Per the caller, they had been trying to reach the doctor, but he is very busy.It was reported that they weren't able to complete the dye test because they couldn't get anything with the catheter.The patient had not gone through withdrawal.It was reported that the pump wasn't helping with neuropathy.The caller was to follow-up with a healthcare provider.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that the patient was not getting pain relief.It was reported that it was unknown if there were any environmental/external/patient factors that may have led or contributed to the issue.It was reported that the dye study was done but they could not aspirate from the sideport.It was reported that the catheter was replaced on (b)(6) 2018 and the device was discarded by the customer.It was reported that the issue was resolved.It was reported that the concentration of dilaudid was 15 mg/ml and that the daily dose remained unknown.No further complications were reported and/or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received via a consumer.It was noted that the catheter was replaced due to having been plugged somehow, was not functioning, and the patient was not getting medication.

• 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: 7549589
• MDR Text Key: 109513809
• Report Number: 3004209178-2018-12027
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 09/12/2018; 08/08/2018
• Supplement Dates FDA Received: 08/03/2018; 09/14/2018; 10/04/2018
• Date Device Manufactured: 02/24/2016
• 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: 57 YR