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

Model Number 8637-40

Device Problem Failure To Service (1563)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/01/2014

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient had not seen any improvement with the pump.Per the patient, the pump was working fine but the therapy had not been effective since the pump was implanted.The patient had the dose adjusted every 3 weeks and had the pump refilled the day prior to the report.The device system delivered baclofen.Additional information was received from a consumer regarding a patient receiving intrathecal baclofen at an unknown dose and concentration via an implantable pump for intractable spasticity and spinal cord injury/spinal cord disease.It was reported that the patient ¿wanted to know the reason he got the implant¿.It was noted that the patient got the pump in (b)(6) 2014 because he had spinal stenosis cervical surgery on his neck and lower back.The patient did not see the pump helping at all and did not see it ¿doing good at all".The patient kept going back to his healthcare provider (hcp) to increase and decrease the pump.The patient¿s hcp ¿did not know why either¿.They had decreased the patient¿s meds now.There were no further complications reported.Additional information was received from a patient.It was reported that the patient had worked with their healthcare professional (hcp) regarding discontinuing therapy and the hcp recommended that the pump not be removed.The patient said that their last refill was supposed to have been (b)(6) 2017 however he didn't have a refill.Patient said in (b)(6) 2018, he started taking oral baclofen.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient on 2018-dec-19.It was reported they stopped using the pump because it was not helping him.The hcp was ¿increasing and decreasing but nothing was working.¿ he has not had the pump refilled in almost 2 years.He is (now) taking baclofen pills (1 and half) every day, and ¿the medication was set to a very low setting.¿ there were no further complications reported/anticipated.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7562847
• MDR Text Key: 109894833
• Report Number: 3004209178-2018-12424
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 12/20/2018
• Date Device Manufactured: 06/02/2014
• 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: 57 YR