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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC SYNCHROMED 2

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MEDTRONIC MEDTRONIC SYNCHROMED 2 Back to Search Results
Model Number 8637-40
Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Inadequate Pain Relief (2388)
Event Date 01/04/2017
Event Type  Injury  
Event Description
Pain pump motor stalling. Patient is a (b)(6) who was transferred by ambulance to this facility due to malfunction of his pain pump. The patient endorses on friday he began having a lot of lower back pain and noticed his pain pump likely was not working. He states he continued to have pain through the weekend and decided to go to hospital for evaluation. It appears the patient had a pain pump placed in 2013 by dr. (b)(6) for chronic lower back pain. He states he's never had any problems in the past with his pump and denies any injuries or falls. The patient has extensive past medical history including cad, hyperlipidemia, hypertension, chf, anxiety and depression, gerd, in remission from lip and prostate cancer, sleep apnea and type 2 diabetes. He currently denies any fevers, recent illness, chest pain, shortness of breath, abdominal pain, diarrhea, dysuria, hematuria, hematochezia, loss of bowel or bladder function and no weakness of extremities. He reports he is very uncomfortable and is having a lot of pain currently after riding an ambulance. System found to be intact. I was able to aspirate a small amount of cerebrospinal fluid from the catheter.
 
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Brand NameMEDTRONIC
Type of DeviceSYNCHROMED 2
Manufacturer (Section D)
MEDTRONIC
savannah GA 31404
MDR Report Key6232491
MDR Text Key64258650
Report NumberMW5067095
Device Sequence Number1
Product Code LKK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/05/2017 Patient Sequence Number: 1
Treatment
CATHETER 8784 NEURO - LOG411699; CATHETER 8784 NEURO 8784 MEDTRONIC (B)(4) ; MEDTRONIC, N/A 1 IMPLANTED ; N/A 1 IMPLANTED. ; PUMP 8637-40 SYNCHROMED MEDTRONIC (B)(4); PUMP 8637-40 SYNCHROMED MEDTRONIC - LOG411699
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