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

Model Number 8637-20

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

Patient Problems Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 8781, serial/lot #: (b)(4), implanted: (b)(6) 2017, product type: catheter, ubd:15-nov-2018, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving gabalon with an unknown concentration and daily dose of 47 mcg/day via an implantable pump for familial spastic paraplegia. It was reported that on (b)(6) 2017 the patient complained that effect of the drug was different depending on the day and a catheter kink was suspected. It was reported that the patient was being monitored. On (b)(6) 2018, it was reported that afterwards, effect of the drug was observed but was sometimes insufficient depending on the day. Catheter contrast study was attempted but was not performed because drug could not be aspirated via the catheter access port (cap). Catheter kink was suspected because taking 3d-ct images and drug aspiration via the cap were unable to perform. It was reported that on (b)(6) 2018, that because effect of the drug was observed on (b)(6) 2018 and (b)(6) 2018, the patient condition is being under observation. Regarding catheter replacement, it has been consulted with the patient. It was reported from the physician that the catheter length between the anchor and the connector might be too long. More attention was paid for about indura catheter than ascenda catheter. It was reported that the ascenda catheter was thought not to be kinked easily because of hardness. It was reported that the spinal catheter might have been cut short, so that the catheter might be long when placing and might be slightly kinked. It was reported that the classification of severity of the event was 3 (serious) and the event was unrecovered. It was reported that the causality of the event was not related to the drug, catheter, pump, or programmer and related to the surgical procedure. No further complications were reported and/or anticipated.

Manufacturer Narrative

Product id (b)(4) lot# n680972005 serial# implanted: (b)(4) 2017 explanted: product type catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received. It was reported that the cause of the catheter kink/patient symptoms was undetermined. It was reported that no further action/intervention was taken or planned. It was unknown if the catheter was to be explanted/revised. It was reported that the therapy is effective so a wait-and-see approach is taken and the devices are still in use. No further issues have been reported. No further complications were reported and/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: 7607079
• MDR Text Key: 111312530
• Report Number: 3004209178-2018-13574
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial