MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Failure To Service (1563); Intermittent Infusion (2341); Device Displays Incorrect Message (2591)

Patient Problems Muscle Spasm(s) (1966); Muscular Rigidity (1968); Pain (1994); Sedation (2368)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient via a manufacturer's representative (rep) regarding a patient who was receiving 2200mcg/ml b aclofen at 695.1mcg/day and 12.5mg/ml morphine at 3.950mg/day via an implantable infusion pump for multiple sclerosis.It was reported that the patient experienced increased spasticity, periods of increased sedation, and increased pain.It was reported that a low reservoir alarm occurred on (b)(6) 2017 at 01:02.An empty reservoir alarm occurred on (b)(6) 2017 at 08:24.The patient was admitted to the hospital for the increased spasticity and pain.The patient had spasms of the upper extremities every 3-5 minutes.The patient reported their old doctor stopped managing their pump because they had "missed too many appointments." the patient's primary care physician signed off for them to get their pump filled last june, but they did not currently have a managing physician.The rep spoke with one of the attending physicians and relayed information about the alarm dates, previously infusing drugs and rates, and concern of potential damage to the internal tubing if pump continued to run without medication.No interventions had been taken at the time of the report.The patient was under inpatient medical treatment at the time of the report.The issue was not resolved at the time of the report.The patient status at the time of the report was noted as "alive-no injury." it was reported in the pump logs that a motor stall occurred on (b)(6) 2017 at 15:16 and a motor stall recovery occurred on (b)(6) 2017 at 15:34.No further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer's representative (rep).It was reported that the patient's motor stall was due to a magnetic resonance imaging scan.The cause of the empty pump was the patient not currently having a managing physician.It was reported the pump was still implanted but not in use.No further complications were anticipated/reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6987129
• MDR Text Key: 90554438
• Report Number: 3004209178-2017-22751
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2017
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR