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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 Muscular Rigidity (1968)
Event Date 04/15/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, information was received from an healthcare professional (hcp), regarding a patient receiving gablofen (2,000 mcg/ml, 751. 9 mcg/day) via an implantable pump. It was reported the patient came in for a refill on the date of this call and the pump showed a reset and pump memory error (pme). The hcp checked the pump logs and it showed a low battery reset, pme and safe stated that started (b)(6) 2022 and had another reset (b)(6) 2022. The hcp stated the patient heard the pump alarming approximately 1 week ago and has had increased stiffness and was taking po baclofen.
 
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 Key14241003
MDR Text Key290455702
Report Number3004209178-2022-05409
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/12/2015
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: 04/28/2022 Patient Sequence Number: 1
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