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

Model Number 8637-40

Device Problem Break (1069)

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Foreign Body In Patient (2687)

Event Date 10/05/2017

Event Type  malfunction  

Event Description

Patient had back and leg pain that started decades ago after they slipped on a wet floor and fell holding a fair amount of weight.They've had a number of surgeries and fusions with some complications.They ultimately had an intrathecal pump placed 15 yrs ago.No problems with the pump until 2 years ago, when the pump was replaced.Patient started having problems late last year and earlier this year right after having the pump refill.They had 2 episodes where the drug extravasated and can went into respiratory arrest.It is felt that the pump is not safe and so it has been replaced with saline.Pain is so severe that they are not tolerating going without the intrathecal drugs.Currently on oxycontin 40 mg every 12 hours and dilaudid grams every 2 hours.Had a catheter break and supposedly has a residual piece of catheter in his spine.Also had a cerebrospinal fluid leak around the time that the catheter was replaced.Do not know where the spinal catheter is or whether the broken spinal catheter could be sitting half out of the spine.Also do not know if current catheter is still connected and patient or what spine looks like in case i have to replace the entire catheter system.Manufacturer response for synchromed ii programmable pain pump, medtronic (per site reporter): representative would like to have the device as soon as we are through with our reporting.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 18000 devonshire street; northridge CA 91325
• MDR Report Key: 7024339
• MDR Text Key: 91830511
• Report Number: 7024339
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8637-40
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 68 YR
• Patient Weight: 122