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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Volume Accuracy Problem (1675)

Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); Muscle Spasm(s) (1966); Muscle Weakness (1967); Overdose (1988); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Decreased Respiratory Rate (2485); Sleep Dysfunction (2517)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving baclofen 3,000.0 mcg/ml at 600.1 mcg/day via an implantable pump for an unknown indication for use.It was reported that on (b)(6) 2018, the patient had a magnetic resonance imaging (mri).It was reported that the patient became unwell and was showing symptoms of baclofen withdrawal.The patient came to outpatient and pump telemetry was read.The pump logs were provided and indicated that there was a motor stall that occurred on (b)(6) 2018 at 15:24, a "stopped pump period may exceed tube set" that occurred on (b)(6) 2018 at 15:24, and a motor stall recovery occurred on (b)(6) 2018 at 16:28.The logs also indicated that an active, audible alarm was silenced on (b)(6) 2018 at 16:24.No further complications were reported and/or anticipated.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a foreign manufacturer representative.It was reported the pump had not been explanted.The patient elected not to use intrathecal baclofen and not to have another surgery, so the pump and the catheter system had been emptied, filled with sterile water and programmed at the minimal infusion (shelf mode).There was no recent record of the patient¿s body weight, but the patient did not weigh more than (b)(6).

Manufacturer Narrative

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

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative.It was reported the cause of the overdose symptoms was not determined, and the patient's age at the time of the event was not available.

Manufacturer Narrative

Updated (withdrawal no longer applies) b6 updated (patient code no longer applies).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative.It was reported that the patient did not present with cessation of intrathecal baclofen therapy but had all the symptoms and signs of overinfusion of baclofen.The hcp clarified that the patient presented to the hcp with baclofen overdose symptoms on 2018 (b)(6), not baclofen withdrawal as the hcp previously mentioned (even though the patient mentioned increased spasms for 4 days before presenting with an inability to keep himself awake).The patient experienced symptoms of excessive drowsiness, awakening then lapsing into sleep again, low respiratory rate, lapses/impairment of recent memory (could not recall the events properly what went on in the preceding 24 hours), extremely floppy legs and trunk.On 2018 (b)(6), the pump was interrogated and put in shelf-mode at ¿18 mcg of baclofen dose since 2018 (b)(6) 1800 hours.¿ the patient still had flaccidity of both legs on the morning 2018 (b)(6), and the hcp was keeping the shelf-mode dosage going with further review to occur on 2018 (b)(6).The hcp disagreed with any conclusions of ¿probable blockage of the tubing and replacing the pump¿.The hcp initially could not see the clinical indication of subjecting the patient for surgery on the available clinical findings at present (an overinfusion clinical symptom complex).The hcp would be continuing to keep a close watch, and the patient had been advised to contact the center.It was later clarified on 2018 (b)(6) that the hcp now planned to replace the pump even though the patient still did not have any significant spasms.The pump reservoir was aspirated on the morning of 2018 (b)(6).Telemetry showed 1.9 ml, but the actual reflux was 3.9 ml.The hcp inquired if it was possible the pump delivered a higher dose by restarting itself on 2018(b)(6) or 2018(b)(6) when the patient was struggling to keep himself awake.The pump would be returned to the device manufacturer.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7650819
• MDR Text Key: 112741111
• Report Number: 3004209178-2018-14664
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/28/2018; 08/10/2018; 08/22/2018
• Supplement Dates FDA Received: 07/03/2018; 08/10/2018; 08/22/2018
• Date Device Manufactured: 12/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0591-2009
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention