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

Model Number 8637-40

Device Problems Nonstandard Device (1420); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 05/21/2020

Event Type  Injury  

Event Description

[date redacted] history of present illness: patient had generator replacement on [date redacted].For the past 4 months the pump is not working well.Despite conservative measures, patient continues to experience debilitating chronic spasticity.Dr has offered baclofen pump catheter and generator replacement.Patient is here today requesting to proceed with surgical intervention.Apparently, there is a recall for the pump generator also.Dye study to evaluate intrathecal catheter was unsuccessful and determined catheter was not patent.[date redacted].Preoperative diagnosis: failure of intrathecal baclofen pump.Postoperative diagnosis: failure of intrathecal baclofen pump.Procedures: removal of intrathecal baclofen pump.Replacement of intrathecal baclofen pump.Placement of intrathecal catheter, connecting of catheter, filling of pump with baclofen in reduction to half dose.[date redacted] surgical pathology.Gross description.The specimen is received for fresh submitted as "malfunctioning baclofen pump" and consists of a 7.5 x 7.5 x 2.5 cm pump.The specimen contains identification, medtronic synchromed ii 8637-40-(b)(4), medtronic incorporated, usa.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave., n.e.; minneapolis MN 55432
• MDR Report Key: 10118492
• MDR Text Key: 194036006
• Report Number: 10118492
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2020
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 14235 DA
• Patient Weight: 84