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

Model Number 8637-20

Device Problems Electromagnetic Interference (1194); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2022

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving compounded baclofen with concentration 2,000.0 mcg/ml at a dose rate of 364.5 mcg/day via an implantable pump.The patient¿s medical history included 2011 traumatic incomplete spinal cord injury at c5 due to a bicycle accident.Traumatic incomplete paraplegia motoric and sensory c5 (ais-d) as a result of a bicycle accident, with myelum contusion at c3 to c5 in 2011 was further indicated.The patient was also noted as having had a hypersensitivity reaction to amoxicillin (date not specified), delirium which was not known before, and (b)(6) (brmo not known).The patient had no treatment restrictions.A spinal catheter and subcutaneous port were placed for intrathecal baclofen test on (b)(6)2021.After a successful test with intrathecal baclofen administration in therapy resistant spasticity, implantation of the pump occurred (b)(6) 2021.They connected the intrathecal catheter to the pump and removed the subcutaneous port ((b)(6) 2021).After a two-month titration phase (initially at a rehabilitation center and subsequently a t home), the oral spasmolytics (baclofen and sirdalud) were phased out and the pump was set to a day-night rhythm.At a baclofen dosage of 282.5 mcg/day, the patient was more or less free of symptoms of spasticity and pain.It was further reported that the patient underwent magnetic resonance imaging (mri) on 2022.The mri was described as 1,5 tesla.The patient and patient¿s mother were instructed about possible alarms.It was noted that 3.5 hours after the mri, a specialized nurse phoned the patient.No alarms were heard, and the patient had unchanged complaints of spasms.A new refill of the pump was planned to occur (b)(6) 2022.The low reservoir alarm was to occur (b)(6) 2022.At the pump refill appointment on (b)(6) 2022, the initial pump interrogation showed service codes 234 and 232 regarding a critical alarm for motor stall (03) and critical alarm regarding pump stopped for longer than 48 hours.The patient did not hear any pump alarm the past month.The log showed a motor stall occurred on (b)(6) 2022.The patient was not experiencing any underdose symptoms.It was indicated that the patient underwent an mri scan on (b)(6) 2022, approximately 15 minutes before the motor stall.After the mri scan was performed, the pump however was not interrogated on (b)(6) 2022.The first interrogation later occurred on (b)(6) 2022.At that interrogation, a motor stall was seen in the logs and the pump alarm started to sound.A critical alarm was occurring every 10 minutes.The logs indicated that a critical alarm regarding motor stall occurred on (b)(6) 2022 at 17:57 followed by a critical alarm regarding pump having stopped longer than 48 hours on (b)(6) 2022 at 17:57.A second interrogation had been performed on (b)(6) 2022, which showed the pump was stopped for 881 hours and 4 minutes.The pump was interrogated three times on (b)(6) 2022 and the logs were checked.It was indicated that the pump went into ¿telemetry mode¿.Regarding factors that may have led or contributed to the issue, mri was indicated.Regarding the clinical picture of the patient the following was noted; spastic, same as before mri, no complaints matching withdrawal syndrome, and patient responded adequately and clear.The manufacturer technical services had been contacted.It was reviewed that ¿telemetry mode" is a state in which the pump is able to communicate with the clinician programmer.It was further reviewed that while in this state, the pump infuses normally; however, some error logging and the audible alarm for motor stall are suspended.If the pump switches into telemetry mode due to emi, the pump resumes drug delivery after leaving the mri magnetic field; however, pump motor stall and motor stall recovery detection function is not active until the post-mri pump interrogation ends telemetry mode.Because the pump was not interrogated after the mri, the pump was still in telemetry mode.The motor stall was not recorded in the logs until the pump was later interrogated again with the clinician programmer tablet.The expected pump reservoir volume on the printout of the pump indicated 2.9 ml.The pump reservoir was accessed and the actual reservoir volume aspirated was 3.1 ml.They concluded from this that the pump had been dispensing medication for the past 36 days, which explained why the patient did not develop a withdrawal syndrome.The pump was filled with baclofen 2000 mcg/ml and the dosage in flex mode was unchanged.The pump was to be monitored and replaced if necessary.It was unknown if the issue was resolved as of (b)(6) 2022.It was indicated that there was no follow-up plan at the moment as of (b)(6)2022, and the physician who was to decide was currently absent.No surgical intervention occurred and no surgical intervention was planned.The patient was without injury regarding their status as of 2022.Additional information was later received from a foreign healthcare provider via a company representative on (b)(6) 2022.When the pump was interrogated, the alarm was heard for the first time.After 10 minutes the alarm heard again and the alarm was then prolonged from 10 minutes to 2 hours (pump was then updated).In t he third log it was visible that pomp motor stall was restored (recovered) on (b)(6) 2022 at at 12.05 pm.In meantime there was contact by telephone with the physician.In the afternoon on (b)(6) 2022 an uncomplicated pump filling procedure was performed.The pump/devices remained implanted in the patient.

Manufacturer Narrative

Concomitant medical products: product id: 8781, lot#: unknown, implanted: (b)(6) 2021, product type: catheter.Motor stall recovery following and mri upon re-interrogation.Report of a volume discrepancy at refill (within +/- 14.5% pump flow rate accuracy specification of the pump; 1.17% less drug delivered than expected).If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14250840
• MDR Text Key: 290801752
• Report Number: 3004209178-2022-05459
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• 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: 04/14/2022
• Initial Date FDA Received: 04/29/2022
• Date Device Manufactured: 10/06/2020
• 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 Age: 25 YR
• Patient Sex: Male