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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 Problems Disconnection (1171); Detachment of Device or Device Component (2907)
Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Pain (1994); Sepsis (2067)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
Continuation of medical devices: product id neu_unknown_cath, product type catheter. Information references the main component of the system. Other relevant device(s) are: product id: neu_unknown_cath. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via legal regarding a patient receiving unknown medication (dose and concentration unknown) via an implanted infusion pump. The indications for use included chronic low back pain and spinal pain. It was reported that the patient's pump was implanted in (b)(6) 2017 (note: this conflicts with device records which indicate the pump was implanted in (b)(6) 2017) and after issues with a spinal leak, the patient finally got the relief they were hoping for. Three weeks later, the patient started having more back pain. After many trips to the doctor, the patient was in the hospital with a pump that had separated from the catheter. The patient ended up in the hospital for six weeks except for a three day break. It was noted that there were many surgeries, the pump was removed, and the patient spent a week in neuro-intensive care at which time they became septic from an infection. Due to the severe infection, the patient had to see an infectious disease doctor for several months. The patient spent several months healing, utilizing intravenous (iv) "pick" lines at home, and went back to oral pain medications. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7704649
MDR Text Key114537708
Report Number3004209178-2018-16238
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 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2017
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/09/2016
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: 07/19/2018 Patient Sequence Number: 1
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