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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 Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Discomfort (2330)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 14-mar-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving hydromorphone (unknown dose and concentration) and bupivacaine (unknown dose and concentration) via an implantable pump. It was reported on (b)(6) 2019 the patient reported unsatisfactory analgesia. On (b)(6) 2019 a cervical magnetic resonance imaging (mri) did not visualize the catheter tip in cervical spine (previously at c5). On (b)(6) 2019 a catheter access port (cap) contrast study was performed and they were unable to aspirate the side port. On (b)(6) 2019 examination revealed tenderness to palpation at the superior border of the pump pocket. On (b)(6) 2000 surgical observation revealed they were unable to visualize or aspirate cerebrospinal fluid (csf). On (b)(6) 2020 a spinal catheter revision occurred where the spinal segment of the catheter was explanted/removed and replaced. On (b)(6) 2020 a pump pocket revision occurred where the pump was repositioned. The outcome of the event resolved without sequelae on (b)(6) 2020. The device diagnosis was other catheter migration and catheter occlusion and the clinical diagnosis was unsatisfactory analgesia and painful pump pocket. The etiology of the event (catheter migration) indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was possibly related. The etiology of the event (catheter occlusion) indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was unlikely related. The etiology of the event (pain pump pocket/pump revision) indicated the relationship of the event to the device or therapy was possibly related and indicated the relationship of the event to the implant procedure was possibly related. The incisional site/device tract was pump pocket. The event date was (b)(6) 2019. No further complications were reported.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10090241
MDR Text Key196566558
Report Number3004209178-2020-09166
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,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/04/2018
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: 05/26/2020 Patient Sequence Number: 1
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