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

Model Number 8637-40

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Pain (1994); Sepsis (2067)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id neu_unknown_cath, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_cath.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via legal regarding a patient receiving unknown medication (dose and concentration unknown) via an implanted infusion pump.The indications for use included chronic low back pain and spinal pain.It was reported that the patient's pump was implanted in (b)(6) 2017 (note: this conflicts with device records which indicate the pump was implanted in (b)(6) 2017) and after issues with a spinal leak, the patient finally got the relief they were hoping for.Three weeks later, the patient started having more back pain.After many trips to the doctor, the patient was in the hospital with a pump that had separated from the catheter.The patient ended up in the hospital for six weeks except for a three day break.It was noted that there were many surgeries, the pump was removed, and the patient spent a week in neuro-intensive care at which time they became septic from an infection.Due to the severe infection, the patient had to see an infectious disease doctor for several months.The patient spent several months healing, utilizing intravenous (iv) "pick" lines at home, and went back to oral pain medications.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7704649
• MDR Text Key: 114537708
• Report Number: 3004209178-2018-16238
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 07/09/2016
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR