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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Communication or Transmission Problem (2896); Protective Measures Problem (3015); Intermittent Communication Failure (4038)
Patient Problems Sweating (2444); Weight Changes (2607)
Event Date 07/02/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional. It was reported that the cause of the pump flip was unknown. The patient had recently lost a lot of weight and was caring for her grandson.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was receiving dilaudid at an unknown concentration and dose via intrathecal drug delivery pump for spinal pain. It was reported that the patient was trying to bond her personal therapy manager (ptm) with her pump, but she was getting a poor communication message on the ptm screen ((b)(6) 2018). Her pump may have flipped or stopped working when she got adjusted at the chiropractor, and went through a metal detector on the same day ((b)(6) 2018). The patient was sweating more because she was unable to get her bolus. Troubleshooting was performed: the patient pushed the selector key to bond the ptm to the pump; she was getting the poor communication message when she did so. The patient was redirected to follow up with her healthcare provider. No further complications were reported. Additional information was received from the healthcare professional. It was reported that the pump was flipped, which caused the poor communication. An x-ray was taken, the pump was flipped manually, and a bolus was able to be given. The poor communication, sweating and bolus issue were resolved. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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 PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7698860
MDR Text Key114841964
Report Number3004209178-2018-16047
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,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2019
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/28/2018
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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