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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 Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems Dyspnea (1816); Pain (1994); Therapeutic Response, Decreased (2271); Loss of consciousness (2418); Ambulation Difficulties (2544); No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2018
Event Type  Injury  
Manufacturer Narrative
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 unknown drug via an implanted pump. The indication for use was spinal pain. It was reported the patient's new pain pump was not working.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a consumer reported the patient experienced the pump not working within the first two years between 2016-2017. It was noted the patient needed more medication for pain. The patient had to buy a scooter to move around because they couldn't walk. The patient also uses ice packs at all times. The patient's pain levels were at 10 and had to go to the emergency room. The patient stated the pump has been a disaster and had to change their life due to the uncontrolled pain. A myelogram dye study was performed in 2018 as well as ct scans, mri's, injections, etc in the previous years. It was unsure if the issue was resolved as the patient's pain was still at a 10 and still needed a back brace and ice packs all the time. The patient's weight was noted as (b)(6) to (b)(6). The patient had to sell their car as they could not drive or use a walker. It was noted the pain pump was ok in the beginning (2012) but each year the pump gave less pain relief. The patient was in and out of hospitals, ambulances, and the emergency room many times. Omitted information pertaining to (b)(4) pain; unable to aspirate, granuloma.
 
Manufacturer Narrative
The previously reported conclusion codes no longer apply to this event and have been updated. Patient codes have been updated to include (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2019-dec-02, additional information was received from the patient. It reported the patient was currently receiving dilaudid (unknown dose and concentration). The patient reported they just came out of the hospital for 10-12 days due to pain and stated their pump was not working. The patient went to the hospital because they couldn't breathe, turned purple and passed out. The patient stated they thought they were having a pulmonary stroke, but it turned out her symptoms were due to excruciating pain. The patient stated they were in the intensive care unit (icu) to manage their pain and was placed on oxygen. The patient stated they were given back-up medication. The patient also mentioned the symptom of incontinence. The patient stated they felt as though her pump has "never worked" since it was implanted. The patient provided all different timelines during the call when asked, but ultimately stated they have had issues since their pump was replaced on (b)(6) 2018. The patient mentioned they were given gel packs and ice packs for their pain. The patient would be going to their hcp office for their pump tomorrow via ambulance transport.
 
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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 Key7538309
MDR Text Key109056758
Report Number3004209178-2018-11678
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/13/2018
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: 05/23/2018 Patient Sequence Number: 1
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