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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); Output Problem (3005); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, lot/serial#: (b)(4), implanted: (b)(6) 2017, product type; catheter, ubd: 31-jul-2019, 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 bupivacaine and morphine at unknown concentrations and dosages via an implantable infusion pump.The indication for use was noted to be non-malignant pain.It was reported that the patient's pump was implanted on (b)(6) 2017 and the pump was working in the beginning but then it stopped helping the patient's pain.This was discussed with the patient's health care provider (hcp) and they ended up doing a revision surgery "maybe 3 months ago" and had to "repair the pump" because they "found it wasn't working¿ they had to re-route it or something".They didn't think the surgery worked because it was "still not working".The caller didn't know any other details of the issue.The caller was redirected to follow up with the hcp to discuss concerns.They noted they were going to the hcp's office the next day to have "some tests done".No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer on 2019-jul-01.It was reported that when the pump was replaced in (b)(6) 2018 or (b)(6) 2018 and the drug was increased (note: this conflicts with the previous report that the pump/catheter were revised rather than a pump replacement), it was found that none of the drug was going to the spine and it was going to the tissue.Since the replacement, the patient's pain was still uncontrollable.When asked to clarify whether the pump or catheter was replaced, the reporter confirmed they thought it was the pump.The patient had stage 3 kidney disease since (b)(6) 2018 and diabetes, and the kidney hcp said a lot of the increase in the disease was because the other hcp told the patient to take aleve, motrin, etc.In the beginning it wasn't so bad, but over time it had gotten worse.Additional information was received via a consumer and also a friend/family member of the patient.The patient was diabetic, and their diabetes had damaged their nerves which was the reason the pump was implanted.The patient¿s diabetes was confirmed as pre-existing and that the patient has had it for 20 years.The patient still had his hip pain that began three months after the implant surgery.The date of the event was unknown.When standing up for 20 minutes, the patient had to sit down on one side to get some relief.The patient wanted a second opinion on his pump due to his pain.Physician listings were provided as requested.It was noted that the pump had moved during the first implant surgery and that a second surgery was required.It was indicated that it was possible that it¿s been a year.The date of event was unknown.Regarding the date of the event, it was noted that the physician would know.The patient was told that they had used a sonogram or a ¿special machine¿.The secondary caller (friend/family member) indicated at the time of the report that the patient¿s catheter was replaced, but that it didn't move.Regarding the medication that was in the pump at that time, it was indicated as being morphine that was normally sent in a tube.The previous and current concentration and dose rate of morphine was unknown.It was further reported that they were calling to find out the success rate of the patient¿s morphine shots that he was getting every month and half or two months for the past five to seven months.Regarding if these were actual shots or refills, it was clarified that they were shots.The healthcare provider would give the patient small amounts of morphine shots because of blood pressure.The reporter was redirected to the healthcare provider to discuss drug related questions / concerns.
 
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Brand Name
SYNCHROMED II
Type of Device
PUMP, 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 Key7742870
MDR Text Key115817779
Report Number3004209178-2018-17250
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169530119
UDI-Public00643169530119
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 Other
Type of Report Initial,Followup,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/28/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/01/2018
Initial Date FDA Received08/02/2018
Supplement Dates Manufacturer Received08/08/2018
07/01/2019
Supplement Dates FDA Received10/04/2018
07/16/2019
Date Device Manufactured07/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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