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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 8637-20
Device Problems Migration or Expulsion of Device (1395); Protective Measures Problem (3015)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_cath, lot# unknown, product type: catheter. Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare provider (hcp) via social media ((b)(6)) regarding a patient who was receiving morphine (unknown concentration and dose) via an implantable pump for abdominal pain from advanced pancreatic cancer. It was reported there was excellent pain control with the spinal infusion pump (synchromed ii) during the first 6 months. The patient was under chemotherapy treatment. Afterwards, the patient started complaining of a progressive increase of their habitual pain, despite increasing morphine daily dose and adding bupivacaine. The patient needed repeated high daily doses of short acting fentanyl. During the next pump refill, continuous fluoroscopy was done to check the catheter. The hcp couldn't confirm it, because only the tip of the catheter was radiopaque and it was difficult to see. Finally, a ct scan was made and informed by a radiologist, describing the stability of the tumor and the misplacement of the catheter. The catheter was placed in a subcutaneous plane, so the hcp went again to surgery. Further complications were not reported.
 
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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 woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8612205
MDR Text Key145125479
Report Number3007566237-2019-01072
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/30/2018
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: 05/15/2019 Patient Sequence Number: 1
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