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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7562847
MDR Text Key109894833
Report Number3004209178-2018-12424
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/02/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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