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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 Problem Protective Measures Problem (3015)
Patient Problem Cognitive Changes (2551)
Event Date 12/31/2021
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) and a company representative regarding a patient receiving baclofen (2000 mcg/ml) via an implanted pump. The patient thought the dose was 1020 mcg/day. The indication for pump use was intractable spasticity. The hcp reported that the patient was in the hospital with an altered mental status. The patient was taking oral baclofen but had not had a significant improvement in symptoms, so due to this, the hcp wanted the pump interrogated to make sure it was infusing properly. Additional information was received the same day from a company representative who reported that he went to the er (emergency room) to interrogate the pump and it was alarming. The pump was saying, ¿safe mode - pump in minimum rate mode¿. In safe mode/minimum rate mode the pump was delivering 12 mcg/day. No other alarms were noted in the logs. The patient was at home when the safe mode triggered.
 
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13175686
MDR Text Key283305073
Report Number3004209178-2022-00215
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/09/2017
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: 01/06/2022 Patient Sequence Number: 1
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