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

Model Number 8637-20

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Complaint, Ill-Defined (2331); Numbness (2415); Shaking/Tremors (2515)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, serial#: unknown, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable drug infusion device.The drug being delivered was fentanyl with an unknown dose and concentration.The reason for use was spinal pain.It was reported that the patient had a real bad fall last (b)(6) 2018.She broke her tail bone, pelvis, and right hip.She has seen her healthcare professional (hcp) since then and hasn't had any problems.Yesterday ((b)(6)2019), she noticed a dent in her left butt cheek.When she pushes her finger into the dent she can feel "either the catheter or wire." something is not right and it feels like the end of the catheter.Her hcp has seen her since the fall, but had not noticed the dent before because she wasn't looking there.She has called the hcp's office and is waiting for a response.They delivered a bolus at 12:30am this morning ((b)(6) 2019) because their tail bone was "just screaming." when they got up their whole left leg went numb and started shaking.They can't walk on their leg because they can hardly feel it and can't control it.Since 5:30am this morning they have been having "kinda sorta hard time breathing." she has the shakes.The numbness has been coming and going off and on for last month and last 2 weeks have been really noticeable.She hasn't stayed numb and it goes away after a couple of minutes.The patient wants to know if she should keep her leg up and states "it's right in the hip area near the buttocks." no interventions were mentioned.The patient was to monitor symptoms and seek emergency medical assistance if needed.The patient states they called their hcp's office this morning and are waiting for a response when the office opens.There were no further complications reported/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: 8915579
• MDR Text Key: 155070520
• Report Number: 3004209178-2019-16067
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2019
• Date Device Manufactured: 10/15/2014
• 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 Age: 69 YR