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

Model Number 8637-40

Device Problems Filling Problem (1233); Migration or Expulsion of Device (1395)

Patient Problems Headache (1880); Muscular Rigidity (1968); Pain (1994); Seroma (2069); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving lioresal (500 mcg/ml at 197.37 mcg/day) via an implanted pump.The patient¿s medical history was chronic spasticity secondary to ms (multiple sclerosis).The indication for pump use was intractable spasticity.The hcp reported that she attempted to access the reservoir and so did the physician, but they were unable to.Per the hcp, they had taken an x-ray.Additional information was received on 16-nov-2021 from the hcp who reported that she filled the patient¿s pump yesterday and the pump had been difficult to access during the refill.She stated that she aspirated the amount she expected and performed a bridge bolus that was still in progress.Per the hcp, the patient called her reporting more pain overnight and now she had a headache, and her spasms were worse than they had ever been.Additional information was received on 29-nov-2021 from another hcp who reported that the patient was seen on (b)(6) 2021 for a dye study and they were unable to complete the catheter study because the pump was flipped.The patient was scheduled with a surgeon for possible reposition of the pump and to check the continuity of the catheter.Per the clinic/procedure notes, the patient had had an increase in spasm on bilateral leg.A 20% dose increase was programmed on (b)(6) 2021.The patient continued to experience increased spasticity on bilateral legs with difficulty walking.She had an er (emergency room) visit and was treated with diazepam with limited benefit.The patient denied any urinary nerve tract infection symptoms; any recent history of constipation; any history of fever or chills or night sweats; and any symptoms of baclofen withdrawal or overdose.On physical exam, the pump in the left lower abdominal quadrant was palpated.Pump position changes with patient position changes was noted.The patient also had some subcutaneous fluid palpated around the pump.There was no swelling edema or any sign of infection.Bilateral extremity increased spasticity was also noted.Since her pump position changed with the patient¿s position it was suspected that the pump was flipped which was confirmed by the ultrasoun d exam.The ultrasound evaluation also showed significant fluid around the pump.An aspiration was attempted under ultrasound guidance and a total of 80 cc of fluid was aspirated.After the aspiration the pump was found to be flipped while the patient was prone.The ultrasound could not find the refill port.The patient was asked to sit on the edge of the table.Her left lower abdominal wall protruded while sitting and the pump was protruded as well with the refill port upward.The pump was then aspirated of about 39 ml and 38 ml of the aspirated fluid was refilled into the pump without any difficulty confirming the previous pump refill was successful.The pump was interrogated and reprogrammed to the previous rate with the new volume of 38 ml.The patient was given norco 5/235 as needed for pain control.Baclofen withdrawal and overdose symptoms were reviewed with the patient and the patient was to contact the office if she experienced any withdrawal or overdose symptoms.It was noted that the patient tolerated the procedure well without any complications.

Manufacturer Narrative

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

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from saol therapeutics.It was reported that the brand of baclofen in the pump was gablofen.On (b)(6) 2021, the patient was taken in for a revision.A fluoro study was completed without difficulty.The catheter was patent.The pump was repositioned and secured.With regards to the patient¿s symptoms, it was noted that muscle spasms and pain continues in legs, spasticity with difficulty walking somewhat improved, and the headache resolved.

• 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: 12932429
• MDR Text Key: 281733797
• Report Number: 3004209178-2021-17985
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Date Device Manufactured: 03/03/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 122 KG