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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 Problem Migration or Expulsion of Device (1395)
Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8784, serial# (b)(4), implanted: (b)(6) 2019, product type: catheter. Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 13-dec-2020, udi#:(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving an unknown drug with an unknown dose and concentration via an implantable pump for non-malignant pain. It was reported that the patient stated that their current lead (catheter) that was implanted was currently dislodged. The patient also stated they were looking for a new doctor in their area. No symptoms were reported. The event date was unknown. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a consumer on 2019-jun-18 indicated the catheter dislodgement was first noticed in (b)(6) 2019. Steps taken to resolve the dislodged catheter included a revision surgery in (b)(6) 2019. Circumstances that led to the dislodged catheter was not known. Symptoms the patient experienced included rash, hives, itching, and a lump on spine. The patient's weight was (b)(6). It was indicated that they hoped it was resolved, but the patient could not confirm. It was also noted the patient has saline in their pump and it was turned on the lowest possible setting. The patient hoped to find a new doctor to fill their pump as they are not about to see their old doctor due to their insurance changing. The patient has been established at a new pain and spine clinic. No further complications were reported/anticipated.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8586915
MDR Text Key144450004
Report Number3004209178-2019-09036
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169630505
UDI-Public00643169630505
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/23/2018
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: 05/07/2019 Patient Sequence Number: 1
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