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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 8637-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Diarrhea (1811); Dyspnea (1816); Erythema (1840); Feeding Problem (1850); Headache (1880); High Blood Pressure/ Hypertension (1908); Unspecified Infection (1930); Pain (1994); Anxiety (2328); Complaint, Ill-Defined (2331)
Event Date 12/05/2017
Event Type  Injury  
Manufacturer Narrative
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 (500 mcg/ml at 24 mcg/day) via an implantable infusion pump. The indication for use was intractable spasticity. The patient had a medical history that included a spinal injury that left the patient bound to a wheelchair. It was reported that the patient had a routine pump replacement surgery in (b)(6) 2017 because the pumps battery was about to die. Although the patient was told he would be out of the hospital the same day he was skeptical and allowed to stay overnight. The day after surgery the patient was getting ready to have an x-ray performed and when he was getting positioned his blood pressure "shot up 100 points" and felt like someone was smashing him in the head with a bowling ball. The reported symptoms lasted about 90 minutes as well as continuing the next day when he would move; the symptoms did not subside until he was given a "number of drugs". The patient was released from the hospital after 4-5 days. The patient was on bedrest for a couple of weeks and when he got up into his wheelchair felt a pain/strange feeling from the pump area. The pump area was noted to be very red and constantly hurting. It was reported that the patient was put back on bed rest for a few weeks and was prescribed antibiotics for about two months. It was noted that the redness went away in about 6-8 weeks but the pain stayed. It was reported that the hcp's were not sure what the problem was but he was given more pain medicine. 5-6 weeks went by and then during a medical exam the patient felt some increased pain (5-10x as bad as it had been before) that later worsened to the point where the patient could not lift his right arm even half way up. It was reported that the patient could not use his arm and it hurt all of the time. It was stated that the patient has had 5 computed tomography scans as well as being on bedrest and while the pain was 10-15 percent better he was still in chronic pain. It was reported that the patient's dose would be tapered down, the pump would be filled with saline and if that works the pump would then be removed. On (b)(6) 2018 the patient's dose would be changed to a mixture that you can only get from the hospital pharmacy; the patient would be going down to the lowest dose of baclofen available (250 mcg/ml at half the rate he was previously getting). It was reported that the patient was nervous of the dose decrease because he had previously gone through withdrawal. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a business partner indicated that the patient had a skin cellulitis and was treated with unspecified antibiotics. It was reported that the patient's increased blood pressure with movement was resolved. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a business partner indicated that the patient had a medication history of spinal cord injury at t3-t4 and bilateral lower extremity spasticity. It was reported that the patient experienced shortness of breath and osteomyelitis in relation to pump replacement surgery. The healthcare provider suspected a foreign body reaction to the pump. No further information was contained in this document.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a business partner indicated that the patient had a medication history of spinal cord injury at t3-t4 and bilateral lower extremity spasticity. It was reported that the patient experienced shortness of breath, osteomyelitis, diarrhea, and feeding concerns in relation to pump replacement surgery. It was reported that the patient's infectious lab work and x-rays came back as negative. The healthcare provider suspected a foreign body reaction to the pump. No further information was contained in this document.
 
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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 Key7538443
MDR Text Key109062722
Report Number3004209178-2018-11687
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,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/23/2018 Patient Sequence Number: 1
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