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

Model Number 8637-20

Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591)

Patient Problems Abdominal Pain (1685); Dizziness (2194); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 12/26/2016

Event Type  malfunction  

Manufacturer Narrative

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 consumer regarding a patient receiving baclofen at an unknown dose and concentration via an implantable pump for intractable spasticity.It was reported in (b)(6) 2016 pump was alarming and sound was consistent with pump alarms.It was noted in (b)(6) 2016 ((b)(6) 2016) the patient heard a single tone alarm, and on (b)(6) 2017 patient heard a two tone alarm.It was noted patient was not sure when the pump was scheduled to be filled.Patient was to follow up with healthcare professional (hcp).It was reviewed hcp can interrogate the pump to see why the pump was alarming.It was noted patient called hcp and left a message.It was reviewed patient should watch how they are feeling and may want to consider the emergency room (er) as they can work with the symptoms the patient was presenting, usually cannot do anything with the pump.It was reviewed any hcp managing the patients care can call the manufacturer to request to have a company representative paged.The symptoms listed below were considered to be a gradual change in therapy/symptoms.In (b)(6) 2016 (the last couple of weeks, (b)(6) 2016) patient was not feeling well.It was stated patient had not been feeling well, but was not sure if it was due to his high blood sugars as they were higher than normal, which happens around the holidays when patient eats what patient should not or more of what patient should not eat.On (b)(6) 2017 patient was feeling worse.It was stated patient thought he was starting to feel withdrawal symptoms.It was noted patient's stomach was bothering him and patient was light headed and generally not feeling well.It was stated patient was not sure if that was due to the pump alarming or not.Additional information was received from an hcp on 2017-jan-10.It was reported that the patient was non-compliant and did not refill pump at prescribed interval.The cause of the single and two tone alarms that were heard were determined to be due to an empty pump secondary to the patient¿s non-compliance.The pump was refilled in the emergency room as intervention taken to resolve the issue.It was indicated that the alarms and withdrawal symptoms of not feeling well and feeling worse, feeling lightheaded, and being bothered by the stomach were resolved.

Manufacturer Narrative

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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6252883
• MDR Text Key: 64912171
• Report Number: 3004209178-2017-00932
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• Date Device Manufactured: 03/28/2016
• 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: 52 YR