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

Model Number 8637-20

Device Problems Disconnection (1171); Fluid Leak (1250); Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Fever (1858); Muscular Rigidity (1968); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, lot#: n515795002, implanted: (b)(6) 2015, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 23-dec-2016, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via a distributor regarding a patient receiving gabalon (unknown concentration at an unknown dose) via an implantable infusion pump. The indication for use was cerebral palsy. It was reported the pump had been replaced on (b)(6) 2022 and there was no particular problem. On (b)(6) 2022, the patient had an outpatient consultation due to a high fever and worsening spasticity. Botulinum toxin (btx) was injected into the lower limbs. The patient was monitored and then went home. On (b)(6) 2022, the patient had a normal temperature and was relieved from tension. The patient went home and would be under observation until the next refill. On (b)(6) 2022, the patient had an outpatient consultation due to worsening spasticity. A refill was performed and there was not an abnormal variability rate. A roller test was performed and it seemed like the pump was working fine, but it was not clear. The patient had tension. A contrast study was attempted, but it was not successful so it was discontinued. The patient went home for observation and adjustment of hospitalization. The patient's hospitalization was re-adjusted on the (b)(6), and after they were to be hospitalized, a roller examination and contrast study would be performed again. The adverse events were considered unrelated to the drug, programmer, and surgical procedure, and unknown if related to the catheter or pump. The attending physician's comments indicated the cause was unknown. Additionally, pump "up/down rotation" was reported. This was considered unrelated to the drug, catheter, pump, and programmer, and unknown if related to the surgical procedure. Further complications were not reported. Additional information was received. On (b)(6) 2022, an "scr" drug formulation was administered via lumbar puncture and was effective. When the system was checked again via x-ray, it seemed that the pump connection was disconnected. After conducting a ct scan, the future plans would be considered by consulting with the neurosurgery department.

• 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: 14756797
• MDR Text Key: 295030315
• Report Number: 3004209178-2022-07918
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 07/20/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/21/2022 Patient Sequence Number: 1