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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 863740
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Fall (1848); Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067); Malaise (2359)
Event Date 06/01/2005
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 who was receiving baclofen (unknown dose and concentration) via an implantable infusion pump for intractable spasticity, other spasticity , and dystonia. It was reported on (b)(6) 2017 that the patient had infection symptoms. The area of the infection was the pocket. The symptoms the patient experienced was an incisional wound opening. It was stated the patient wasn't feeling well and fell and the incision popped open. It was stated the patient was engulfed in (b)(6) so bad that they had to life line the patient to the hospital. It was stated the patient was septic and was so bad they didn't believe the patient would make it. The infection was confirmed and the strain was (b)(6). The event took place in (b)(6) 2005. It was stated that the infection was associated with the fall and the incision opening. Iv antibiotics and oral antibiotics were given. A partial system explant was performed. It was stated the patient was on iv antibiotics for about a month after getting out of the hospital. It was stated the patient was getting 10000 units of "vankamyscine" shots 3 times a day where the pump was implanted. It was also stated that the area of the pump was flooded after they removed it to kill the infection. It was stated the infection was resolved. It was stated the patient had been diagnosed with kidney cancer 4 years ago and lost their kidney. It was stated the cancer was diagnosed after the pump was explanted.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6311129
MDR Text Key100826514
Report Number3007566237-2017-00608
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 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2006
Device Model Number863740
Device Catalogue Number863740
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 Received01/12/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/07/2005
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: 02/08/2017 Patient Sequence Number: 1
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