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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problem Unstable (1667)
Patient Problems Fall (1848); Pain (1994); Therapeutic Response, Decreased (2271); Loss of consciousness (2418)
Event Date 07/01/2017
Event Type  Injury  
Event Description
Information was received from a consumer regarding a patient who was receiving dilaudid at an unknown dose and concentration via an implantable pump for spinal pain. It was reported that the patient had a return of back pain since (b)(6). Then "last week", the patient passed out in her driveway and fell on her face. It was also noted that (b)(6) was "bad for pain" and that the pump was moving in the pocket since (b)(6). Additionally, the patient had been seeing a poor communication error message on her personal therapy manager (ptm) since (b)(6) 2017. However, the patient was able to deliver a bolus after she changed the aaa alkaline batteries in her ptm. It was also stated that the patient did not have a physician and she would need her pump filled on (b)(6) 2017. No further complications were reported or anticipated.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6960970
MDR Text Key89692150
Report Number3004209178-2017-22106
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
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received09/21/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/11/2013
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: 10/19/2017 Patient Sequence Number: 1
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