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

Model Number NEU_UNKNOWN_PUMP

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058); Meningitis (2389)

Event Date 11/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Additional information received from consumer on 2018-jan-08 reported the patient identifying information. Further information was asked/requested and the patient declined to provide further information at this time and stated they will call back. No further complications were reported/anticipated.

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: neu_unknown_cath, serial# unknown, implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: catheter. If information is provided in the future, a supplemental report will be issued. (b)(4).

Event Description

Information was received from a user facility regarding a patient receiving an unknown drug with an unknown dose and concentration via an implantable pump for no known indication for use. It was reported the patient experienced a deep sedated staph and bacterial meningitis due to contaminated device implant 3 weeks earlier. It was noted that it was a patient pump. The patient experienced hospitalization and the event was noted as life threatening. The event date was (b)(6)2017. No symptoms were reported. No further complications were reported/anticipated.

• 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: 7165614
• MDR Text Key: 101657704
• Report Number: 3007566237-2018-00067
• 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: user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: NEU_UNKNOWN_PUMP
• Device Catalogue Number: NEU_UNKNOWN_PUMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 01/04/2018 Patient Sequence Number: 1