MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number NEU_UNKNOWN_CATH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Meningitis (2389)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was receiving dilaudid and bupivacaine at unknown doses and concentrations via a trial catheter for non-malignant pain.It was reported that the patient got bacterial meningitis when they had the pump trial.It was reported the patient got it from the hospital.The patient was put on antibiotics by the pain management doctor.The patient had a rash on their body, and they thought at the time that it was an allergic reaction to the sheets.It was reported that this occurred in 2009.No further complications were anticipated/reported.

• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7634722
• MDR Text Key: 112214127
• Report Number: 3007566237-2018-01878
• 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: Other
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_CATH
• Device Catalogue Number: NEU_UNKNOWN_CATH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2018
• 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
• Patient Age: 46 YR