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

Model Number 8637-20

Device Problems Device Alarm System (1012); Insufficient Information (3190)

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

Event Type  malfunction  

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 a patient who was receiving gablofen (baclofen) 5 mcg 1000 ml via an implantable pump for unknown ind ications for use.It was reported that the patient stated 'about a month ago,' they started hearing 'a faint sound like a truck backing up at the same time every morning.The patient mentioned that i contacted the doctor, informing them about the sound even thou the area was quiet.The patient stated they could not hear the sound for the rest of the day once they left their apartment and when they were at work where it was loud.The patient stated they went to the doctor's office the same day they started hearing the sound, and the doctor checked the pump and logs and 'they didn't see any indication that it went off,' and inquired if that was possible for the clinician programmer to not pick up the event in the logs.The patient stated they have been having smoke alarm issues and did not specifically know where the sound was coming from but did not think their pump alarms are as loud as a smoke detector.An agent did not inquire about critical pump alarm history due to plethora of patient cases and to focus on reason for call.The patient stated they may not see doctor for another week and were told to call clinic if they hear it again.The patient had gablofen 5mcg/1000ml.Additional information received from a health care provider (hcp) indicated that regarding the event date, the patient contacted the office on (b)(6) 2023 reporting alarm sounding and was seen the same day.The hcp reported that no issue was found/sounds heard on exam or alerts found in log check.The hcp also clarified that there was no infusion system related issue and the cause of the symptoms were not determined.Actions/interventions taken included interrogation of the system and review of both critical and non-critical sounds played.The hcp also reviewed when to call office and the patient was instructed to rule out smoke detector batteries weren't low.The patient's hearing sounds was resolved.The hcp stated that per the patient, it only occurred in the morning at the same time.The patient's weight was also provided.When asked about the current status of the patient's pump, the hcp indicated that the pump was still in use.There were no further complaints and the patient's last refill was on (b)(6) 2024.There were no issues found on log check and no symptoms of withdrawal.The hcp also clarified that the patient had 1000 mcg/ml with a 20 ml pump.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from a consumer (con) reporting that they had a handyman come into their home who also heard the beeping.The patient stated their healthcare provider (hcp) played the critical and noncritical alarms for them in office but stated they could barely hear either of them.The patient stated for awhile it was every morning and then it stopped but started up again this morning.The patient inquired if the pump's alarm volume could be increased and the patient was redirected to their hcp.The patient stated they would discuss with their hcp at their next refill appointment on (b)(6) 2024.

• 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: 18695021
• MDR Text Key: 335249304
• Report Number: 3004209178-2024-04538
• Device Sequence Number: 1
• Product Code: LKK
• 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: Non-Healthcare Professional
• Type of Report: Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2024
• Date Device Manufactured: 09/18/2023
• 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 Sex: Female
• Patient Weight: 42 KG