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

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Fatigue (1849); Muscle Weakness (1967); Neuropathy (1983); Pain (1994); Seroma (2069); Vomiting (2144); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Numbness (2415); Sleep Dysfunction (2517); Electric Shock (2554); Lethargy (2560); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, product type: catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider via a device manufacturer representative regarding a patient receiving an unknown drug via an implantable infusion pump. It was reported that the patient had been having withdrawals for the past two weeks. The felt "jittery, restless leg, vomiting, and stomach pains. "a dye study was performed but the catheter could not be aspirated. When they accessed the reservoir, they aspirated 20ml and they expected 16. 5ml. The caller stated they are looking to schedule a removal for the full system.

• 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: 10592741
• MDR Text Key: 208748921
• Report Number: 3004209178-2020-16779
• 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: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/28/2020 Patient Sequence Number: 1