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

Model Number 8637-20

Device Problem Infusion or Flow Problem (2964)

Patient Problems Itching Sensation (1943); Muscle Weakness (1967); Lethargy (2560); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 10/27/2021

Event Type  Injury  

Event Description

Information was received from a healthcare provider regarding a patient who was receiving therapy via an implantable pump for intractable spasticity and post spinal cord injury.It was reported that post pump replacement the patient had been somnolent.It was noted that during surgery they did not fully sedate the patient but used local anesthetic.Placing a magnet over the pump was discussed.On (b)(6) 2021 (b)(4) (hcp): additional information received from a healthcare provider (hcp) reported that the patient presented with symptoms of underdose (itching, weakness and spasms) that began at 5 pm on the evening of (b)(6) 2021.The hcp stated that two weeks ago the patient was admitted for a baclofen overdose and had been discharged and well managed until today.The hcp stated that the pump was not audibly alarming.The hcp was requesting the pump to be interrogated.On (b)(6) 2021 lfc (hcp): additional information was received from the healthcare provider indicated that the pump programming was increased by 10% (a 75 mcg bolus and 100 mcg bolus were also give) but the issue did not resolve.A failed dye study determined that there was a catheter malfunction and it was revised.

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, product type: catheter.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: 12916626
• MDR Text Key: 281603883
• Report Number: 3004209178-2021-17895
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• UDI-Public: 00763000422608
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• 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: 11/09/2021
• Date Device Manufactured: 09/27/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female