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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 Problems Device Alarm System (1012); Filling Problem (1233); Volume Accuracy Problem (1675); Improper Flow or Infusion (2954)
Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
(b)(6). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care professional (hcp) regarding a patient in germany who received baclofen 500 mcg/ml at 250 mcg/day via an implantable pump. The indication for use was not provided. It was provided by the hcp that on (b)(6) 2018 there was difficulty refilling the pump. A 4 ml discrepancy also occurred. Further, on (b)(6) 2018 a pump alarm was heard twice, telemetry was performed and the pump logs did not confirm the alarm. The patient¿s family reported that the pump¿s non-critical alarm had been heard while the patient was in the school. The hcp stated that a beeping noise was heard twice the day before. No patient symptoms were associated to the alarm. The hcp also reported that the pump had been effective after implant but that the effectiveness had diminished since. As reported, due to the alarm being heard, problems with the refill, and diminished therapeutic effect the pump was going to be replaced. The patient had experienced spasticity with a gradual change in therapy. No further information was provided nor could be obtained regarding these issues. No further complications were reported/anticipated.
 
Manufacturer Narrative
(b)(4). 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 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 Key7541401
MDR Text Key109160818
Report Number3007566237-2018-01550
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number863740
Device Catalogue Number863740
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 Received09/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/24/2018 Patient Sequence Number: 1
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