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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 Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8596sc, serial#: (b)(4), implanted: (b)(6) 2019 product type: catheter. Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(4), ubd: 22-aug-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving fentanyl (2000 mcg at 1450. 00656 mcg/day), dilaudid (7. 8 mg at 5. 65503 mg/day), and bupivacaine (20 mg at 14. 50007 mg/day) via an implantable pump for unknown indications for use. It was reported that the patient was in the hospital for surgery not related to pump, on (b)(6) 2021, and the catheter was cut during procedure. On (b)(6) 2021, the surgeons accessed that the pump must be removed. The next day the pump and catheters were removed and the issue resolved without sequelae. It was indicated the event was related to the device or therapy and resulted in prolongation of existing hospitalization.
 
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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 Key14337034
MDR Text Key291212431
Report Number3004209178-2022-05872
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 Study,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/25/2019
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: 05/09/2022 Patient Sequence Number: 1
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