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

Model Number 8637-40

Device Problem Premature Discharge of Battery (1057)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Malaise (2359)

Event Date 06/24/2017

Event Type  malfunction  

Event Description

Patient with a medtronic 40 ml intrathecal (it) pump (model #8637-40) implanted approximately 5 years ago, for management of chronic low back and leg pain related to (r/t) failed lumbar spine surgery, was admitted to an outside facility about a month ago with general malaise and elevated bp 200/100, it pump alarming.After several days inpatient, the patient's symptoms resolved, he was discharged.The patient's wife called clinic approximately 2 weeks ago, to give report that the patient's pain remained "out of control" and informed clinic that his it pump was still alarming.At last visit, approximately 2 months ago, the pump's estimated reserve index (eri) /expected battery life = 22 months.On arrival to pain clinic, the day after the patient's wife called, the patient reported his pain as "#9-10/10-terrible." at visit he didn't exhibit any withdrawal symptoms, and vs's were stable.On pump interrogation, it was discovered that the pump was in motor stall occurred approximately 2 days prior to visit to the outside facility, with no indication of recovery.Medtronic representative was in the clinic during the patient's visit, and he reviewed the recent patient history and pump telemetry and confirmed that the patient's pump was not working and will require replacement.With an eri of 21 months, no one expected that the pump would go into stall prematurely.Per the representative's recommendation, the pump was programmed to "minimum rate", and plans are being initiated for a 40 ml pump replacement surgery.The patient has rx norco 10/325 mg one po qid prn to help with pain control until this surgery can be scheduled.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave. n.e.; minneapolis MN 55421
• MDR Report Key: 6848327
• MDR Text Key: 85134829
• Report Number: 6848327
• 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: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2017
• Device Age: 5 YR
• Date Report to Manufacturer: 08/01/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 77 YR