MAUDE Adverse Event Report: MEDTRONIC SYNCHRONIZED II MEDTRONIC PUMP; NEUROMODULATION PUMP

Device Problems Unexpected Therapeutic Results (1631); Defective Device (2588)

Patient Problems Muscle Spasm(s) (1966); Inadequate Pain Relief (2388); Device Embedded In Tissue or Plaque (3165)

Event Date 04/14/2017

Event Type  Injury  

Event Description

Baclofen pump originally placed (b)(6) 2015.Pump was not delivering adequate pain relief to patient.Provider unable to assess whether the pump component or the catheter was malfunctioning.During revision surgery a piece of the catheter broke off.Broken piece remains in pt as consult with neurosurgery indicated there was more risk to the patient to attempt removal, than leaving it in place.

• Brand Name: SYNCHRONIZED II MEDTRONIC PUMP
• Type of Device: NEUROMODULATION PUMP
• Manufacturer (Section D): MEDTRONIC; 710 medtronic pkwy.; minneapolis MN 55432 5604
• MDR Report Key: 6582084
• MDR Text Key: 75909132
• Report Number: 6582084
• Device Sequence Number: 1
• Product Code: LKK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2017
• Distributor Facility Aware Date: 04/14/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR