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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 Inappropriate or Unexpected Reset (2959); Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2021
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 healthcare provider (hcp) via a company representative regarding a patient receiving an unknown medication via an implanted pump.The indication for pump use was multiple sclerosis and intractable spasticity.The hcp reported that he saw an error when updating the pump.When the logs were read it showed a reset, pump reset due to firmware error, and that the pump was at minimum rate.The programmer showed codes 323 for reset, 102 for stopped pump, and 140 for failed update.During the call, the hcp tried to update the pump again, but got a similar error message and it wouldn¿t complete the update.The hcp was asked to enter ptm (personal therapy manager) data even though the patient was not usinga ptm in case that was what was preventing the update from completing and he was able to update.He did hear an alarm during the update; however, it wasn¿t clear how far along the update was when that occurred.He then went back in and programmed to flex dosing, which was his desired mode which disabled the ptm, and he was able to update again.It was noted that the troubleshooting resolved the reported issue.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12729083
MDR Text Key279319513
Report Number3004209178-2021-16214
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169508156
UDI-Public00643169508156
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2021
Initial Date FDA Received11/01/2021
Date Device Manufactured03/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age57 YR
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