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U.S. Department of Health and Human Services

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

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Rash (2033); Skin Irritation (2076)
Event Type  Injury  
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 8703w, serial (b)(4), implanted: (b)(6) 1997, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) regarding a patient who was receiving an unknown drug via an implantable infusion pump for malignant pain, non-malignant pain, intractable spasticity, multiple sclerosis, failed back surgery syndrome, other spasticity, other carcinoma, head/brain injury, other non-malignant pain, rsd/causalgia-complex regional pain syndrome, spine/back, and spinal stenosis. It was reported that the patient contracted an unusual contact dermatitis adjacent to the pump and it was removed. A catheter allergy was reported. Pump removal was noted to have occurred in (b)(6) 2017. Since that time, the patient got better per the hcp. They thought that it was the catheter as the tissue was inflamed where the catheter attached to the pump and on the right side of the abdomen there was redness where the catheter was and the pump was on the left side of the abdomen. The pump was explanted and the hcp assumed the catheter was explanted too, but did not have access to all of the patient's records at the time of the report. The hcp inquired about catheter and other materials and specifications. The event date was asked, but unknown. The patient reportedly wanted another system implanted since recovering from the allergic reaction post implant. 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 a healthcare provider (hcp). The patient had an allergic reaction after 12-14 years of having the catheter. The pump and catheter were explanted and the device manufacturer representative was not sure if they would be returned to the manufacturer. The pump and catheter were in pathology at the time of the report and the dermatologist was testing the catheter. The hcps were trying to figure out of the contact dermatitis was due to the pump or catheter. The hcps were running allergy tests, and trying to identify whether the allergic reaction was pump related. The device manufacturer representative heard that there was skin irritation from the pump connector to the patient's flank running alongside the catheter externally where the catheter was internally. 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 healthcare professional (hcp). It was reported that the pump and catheter were explanted (b)(6)2017. The patient had been tested and appeared to have an allergy to the connector. The pump went to pathology and was no longer in the hcp's possession. The patient weight was unknown at the time of the event. No further complications were reported.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7304164
MDR Text Key101202215
Report Number3004209178-2018-04210
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/14/2014
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 Received04/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/17/2012
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: 02/28/2018 Patient Sequence Number: 1
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