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

Model Number 8637-20

Device Problem Occlusion Within Device (1423)

Patient Problems Muscle Spasm(s) (1966); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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: (b)(6) 2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving gablofen 2000mcg/ml at 254mcg/day via an implantable pump.The indication for use was intractable spasticity.The healthcare provider reported that he completed an indium study on the patient and the dye did not leave the pump pocket.The healthcare provider suspected an issue in the pump/catheter connection.There were no known environmental, external or patient factors that may have led or contributed to the issue.The actions and interventions taken to resolve the issue was the patient was scheduled for a catheter revision on (b)(6) 2018.The issue was not resolved at the time of the report.The patient status was noted as alive, no injury and no further complications were reported.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received by the healthcare provider (hcp) via the manufacturing representative (rep).It was reported the catheter was replaced on (b)(6) 2018 and was discarded by the customer.It was reported the patient had experienced spasms which were worse than their normal baseline.It was indicated the previously reported indium dye study had been conducted on 2018-apr-09.The patient was taken to the operating room on (b)(6) 2018 and the pump pocket was opened and explored.Once the catheter was disconnected from the pump, there was good cerebrospinal fluid (csf) backflow noted through the catheter.The sutureless connector (sc) was changed.Flow was confirmed once again once the sc connector was attached and then again through the catheter access port (cap).The daily dose was reduced to 100 mcg/day per the physician's request.It was reported the issue had been resolved at the time of the report and the patient's status was provided as "alive - no injury." other medications being taken at the time of the event and medical history were not available.

• 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: 7536322
• MDR Text Key: 108981895
• Report Number: 3004209178-2018-11599
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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,Followup
• Report Date: 06/12/2018

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: 05/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 06/12/2018
• Date Device Manufactured: 11/16/2017
• 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 Weight: 50