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

Model Number 8637-20

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

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

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 8780, lot/serial#: (b)(4), product type: catheter; ubd: 30-jan-2020, 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 (hcp) via a manufacturing representative (rep) regarding a patient receiving an unknown medication via an implantable pump. The indication for use was not provided. The patient¿s information was not provided. It was reported during the implant procedure on (b)(6) 2018, the catheter "got caught around some existing plates and screws and bent. " it was reported the patient had severe scoliosis and had quite a big construct. A different 8780 catheter was implanted instead, and the original catheter was discarded. Therefore, the damaged catheter would not be returned. No symptoms were reported. No further complications were reported or anticipated. Additional information was received from the manufacturing representative (rep). The patient's information was provided, and the indication for use was provided as intractable spasticity. The patient's weight was unknown. Regarding the report that the catheter "got caught around some existing plates and screws and bent," no further descriptive information was available. It was indicated this happened when the catheter was being placed during the implant procedure. The reported information was confirmed with the physician/account.

• 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: 8213344
• MDR Text Key: 132266430
• Report Number: 3004209178-2019-00189
• Device Sequence Number: 1
• Product Code: LKK
• 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

• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/28/2019
• 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: 12/27/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial