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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 863720
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2009
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who was receiving morphine, baclofen, and one unknown drug (unknown con centration and dose) via an implantable pump. Indication for use was non-malignant pain and failed back surgery syndrome. The date of the event was approximately (b)(6) 2009. It was reported the pump battery failed. The healthcare provider had been increasing the drug. The pump did not last the full amount of time for normal battery depletion. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via saol. It was reported the patient is caucasian and was (b)(6) year-old at the time of the event onset. On (b)(6) 2015, the patient started treatment with compounded baclofen 425 g/ml at an unknown dose. Concomitant products included alpha-lipoic acid, vitamin b12, biotin, vitamin c, coq-10, vitamin b2, vitamin d3, cytomel (liothyronine sodium), flonase (fluticasone propionate), levoxyl (levothyroxine sodium), magnesium, maxalt (rizatriptan benzoate), milk thistle, nifedipine, nystatin/triamcinolone,ondansetron, pataday (olopatadine hydrochloride), promethazine, promethegan (promethazine), relistor (methylnaltrexone bromide), senokot, skelaxin (metaxalone), trazadone, vivelle-dot (estradiol), voltaren (diclofenac sodium), "vsl #3," wellbutrin (bupropion hydrochloride) and zenpep (pancrelipase). Medical history included non-malignant pain, chronic pain (20 years), nerve pain following laminectomy (2011). On an unreported date, she started treatment with hydromorphone 1000 g/ml at 132. 3 g/day.
 
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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 Key7267512
MDR Text Key100256608
Report Number3007566237-2018-00449
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2006
Device Model Number863720
Device Catalogue Number863720
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 Received03/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/26/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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