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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 8637-20
Device Problems Material Integrity Problem (2978); Insufficient Information (3190)
Patient Problems Muscular Rigidity (1968); Arthralgia (2355); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  Injury  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider, clinical study) regarding a patient who was receiving an unknown drug of an unknown concentration at an unknown dose rate via an implantable pump for unknown indications for use. The patient's medical history included spasticity; multiple sclerosis. Other medications included befact frote, oxybutynin, and pantomed. It was reported that the catheter was dysfunctional. The catheter was explanted and replaced. It was further noted that the pump was also explanted with replacement. There was no additional medical intervention required.
 
Manufacturer Narrative
Concomitant products: product id: 8731sc, lot#: unknown, implanted: (b)(6) 2015, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8731sc, serial/lot #: unknown. 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 Key13845599
MDR Text Key287600775
Report Number3004209178-2022-03564
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2015
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/12/2014
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: 03/22/2022 Patient Sequence Number: 1
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