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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Underdose (2542); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient receiving an intrathecal unknown drug via an implanted pump for an unknown indication.The delivery system was not working and the remote was not sending a signal to release medications.The patient tried to change batteries with no change.Patient symptoms were not reported.Further information was not provided.

Manufacturer Narrative

Information referenced the main component of the system and other applicable components are: product id: 8835, serial# (b)(4), product type: programmer, patient.

Event Description

Additional information was reported by the consumer on (b)(6) 2016.The pump was used to deliver morphine and another unknown drug.The indication for use was post-herpetic neuralgia and spinal pain.It was reported that the personal therapy manager (ptm) was not working very well.Starting about a month prior to the report it sometimes would not deliver and it was getting worse.The patient was supposed to be able to get a bolus every two hours and they try about every three hours.Sometimes they see nothing on the screen.The consumer later reported the ptm was showing an "x" and was unexpectedly declined from a bolus.The patient sometimes experienced pain due to not getting the medicine.It was noted that the patient was always in pain which started years ago, before the pump.It was reported that the patient was scheduled to see their healthcare professional on (b)(6) 2016.

Event Description

Additional information was reported by the healthcare professional (hcp) on (b)(6) 2016.The hcp reported that the troubleshooting performed related to the difficulty communicating with the pump, bolus denial, and blank screen was that the company representative reeducated the patient on ¿proper use.¿ the cause of the issues was that the patient was unclear on the proper use.On (b)(4) 2016, the rep reported that the patient had reported unsuccessful boluses.The patient¿s lockout parameters were 12 boluses/ day with 4 minute duration, the lockout interval was 2 hours and the dose restriction interval was 1 per 2 hours.It was confirmed that the patient¿s lockouts were due to the lockout interval and uplink interference.It was reported that the patient had started having issues in the beginning of (b)(6) 2016.No patient symptoms were reported.The rep later reported that the patient would ¿not rest¿ and a new personal therapy manager was requested for the patient.

Event Description

Additional information was received from the manufacturer representative on 2016-nov-28.It was reported that the patient received a new ptm, but the uplink interference was still occurring.The patient was not feeling the effects of boluses.An appointment was scheduled with the patient's hcp on (b)(6) 2016, and flex programming to automate boluses was discussed.

Manufacturer Narrative

The patient code (b)(4) also applies to this event.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.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5840336
• MDR Text Key: 50969734
• Report Number: 3004209178-2016-15365
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• Date Device Manufactured: 01/21/2016
• 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