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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
Device Problems Activation, Positioning or SeparationProblem (2906); Positioning Problem (3009)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 10/05/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6)2018, product type: catheter. Product id 8782, serial# (b)(4), implanted: (b)(6) 2018, product type catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4); product id: 8782, serial/lot #: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal morphine 1 mg/ml at 1 mg/day [up to 2 mg/day with the personal therapy manager (ptm)] and intrathecal bupivacaine 4. 8 mg/ml at 6. 3 mg/day (up to 9. 3 mg/day with the ptm) via an implantable pump. The indication for use was not reported. It was reported the hcp felt the patient was not getting adequate treatment from the targeted drug delivery (tdd), so they performed a ct scan. They felt the spinal segment may have been in the epidural space; the spinal catheter was implanted epidurally. The distal segment of the spinal catheter was removed, and a new spinal segment was implanted. When the spinal segment anchor was being deployed, it became stuck on the applicator and folded over at the tip (curled over itself). The anchor was removed, and a new anchor was used. Only the back wound was opened, and the rest of the catheter was not removed. The anchor would be returned to the device manufacturer. The distal segment would not be returned as it was discarded by the customer. The issue was resolved. The patient's status was alive - no injury. Environmental, external or patient factors reported that might have led or contributed to the event included the patient having a ¿difficult anatomy with spinal cancer¿. There were no [additional] environmental, external or patient factors reported that might have led or contributed to the event. The patient¿s weight and medical history were unavailable. No further complications were 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 Key7980647
MDR Text Key124325346
Report Number3007566237-2018-03078
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637
Device Catalogue Number8637
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Yes
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: 10/18/2018 Patient Sequence Number: 1
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