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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Protective Measures Problem (3015)

Patient Problems Muscular Rigidity (1968); Nausea (1970); Therapeutic Response, Decreased (2271); Malaise (2359); No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2018

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 health care professional (hcp) regarding a patient receiving gablofen (2000 mcg/ml at 303 mcg/day) via an implantable infusion pump.The indication for use was noted to be intractable spasticity.It was reported that pump interrogation showed a critical alarm occurred on (b)(6) 2018.It was noted safe state was seen in the logs and no other alarms were seen.The caller reported the pump was going to be replaced.The alarm was silenced and the pump was programmed to minimum rate.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from an hcp via a clinical study on 2018-sep-28.It was reported that the patient had an episode of nausea and was feeling poorly with increased spasticity.It was noted that tech services was called, and the cause of the pump shifting into safe state was some unknown external electromagnetic interference.It was further noted that the patient was given 25mg of baclofen on 2018-(b)(6).The etiology indicated that the event was related to the device or therapy and was not related tot he implant procedure.The outcome indicated the event was ongoing.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider reported there were no resets seen in the logs so the hcp reprogrammed the pump and set the dose on 2018-(b)(6).The pump was interrogated on 2018-(b)(6) and was functioning properly with no new events in the logs.The patient's weight was noted as (b)(6) lbs.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider via a clinical study reported the issue resolved without sequelae on (b)(6) 2018.

Manufacturer Narrative

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

Event Description

Additional information was received from a health care professional (hcp) on 2018-sep-27.It was reported that the hcp saw a motor stall in (b)(6) 2018 with an immediate recovery due to an mri.He confirmed that the only other event was the safe state on (b)(6) 2018.The hcp was setting the infusion back to simple continuous at 100 mcg/day.He noted the patient did have withdrawal symptoms but didn't realize it and thought she had the flu, so he was going to start her on a lower dose.The hcp confirmed there was no known event that would have triggered the safe state.He was going to give the patient a bolus and have her stay in the office to monitor the pump and see if it returns to safe state.No further complications were 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: 7907456
• MDR Text Key: 121651559
• Report Number: 3004209178-2018-21497
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: health professional,study
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2018
• Date Device Manufactured: 01/19/2015
• 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): Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 57