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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problems Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2021, product type: catheter. Product id: 8781, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 12-dec-2020, udi#: (b)(4); product id: 8781, serial/lot #: (b)(4), ubd: 31-aug-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving baclofen via an implanted pump. The indication for pump use was intractable spasticity. The patient reported that she had surgery on (b)(6) 2021 for something unrelated to the pump. She stated that when the surgeon was doing the surgery, they discovered that the catheter was ¿really messed up¿ and had been prior to surgery. Per the patient, the surgeon took the catheter out but didn¿t do anything else. The patient was wondering how she could get the pump turned off. She stated that she was traveling and was no where near her managing physician.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13091907
• MDR Text Key: 282814968
• Report Number: 3004209178-2021-19029
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial