• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Disconnection (1171); Filling Problem (1233); Kinked (1339); Migration or Expulsion of Device (1395); Unstable (1667); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978); Positioning Problem (3009)
Patient Problems Dyspnea (1816); Emotional Changes (1831); Fatigue (1849); Hyperventilation (1910); Memory Loss/Impairment (1958); Overdose (1988); Pain (1994); Seizures (2063); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Dysphasia (2195); Brain Injury (2219); Anxiety (2328); Discomfort (2330); Complaint, Ill-Defined (2331); Coma (2417); Loss of consciousness (2418); Sweating (2444); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551); Lethargy (2560)
Event Date 10/07/2014
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer. It was reported that the patient had an overdose with her pain pump, and she was in a coma before. It was reported that the device was now explanted. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). It was reported that a flipped pump was confirmed. The hcp was not able to fill the patient's pump which led her to believe the pump had flipped. The patient had manually flipped the pump back herself and the hcp was able to fill the pump after just fine. The hcp told the patient at that time that if the pain control was not good, to contact the office; however, the patient never contacted them about that. The hcp wanted to know if there was any protocol where the hcp had to perform an x-ray if there was a flipped pump as in this patient's case they did not perform an x-ray. No further action was needed at this time as the patient had their pump removed 2017(b)(6).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare provider (hcp). It was reported that the pump flipping was related to the patient's obesity (b)(6). Although the patient mentioned that the pump was not working, the hcp noted that the patient was wrong. The catheter was noted to be flowing at (b)(6)2016 surgery. Xray on (b)(6)2016 showed spinal catheter in soft tissues. Patient did not show upfor the (b)(6)2016 appointment. Although it was mentioned that the patient had a bmi of (b)(6), it was stated that the patient had a bmi of (b)(6) on (b)(6)2016. No further complication was reported. Additional information was received form the consumer. It was reported that healthcare provider (hcp) adjusted the pump and lowered it by 7%. It was noted that "she lied" since there was no printout or scan for that date. No further complication was reported.
 
Manufacturer Narrative
Other applicable components included: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2017, product type: catheter; product id: 8780, serial# (b)(4), implanted:(b)(6) 2014, explanted: (b)(6) 2015, product type: catheter. Correction was made to include life treating as an outcome. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp). It was reported that the catheter migrated after (b)(6) 2016 surgery. There was no telemetry slip from (b)(6) 2016 appointment and no pump adjustment was needed. The hcp found nothing in (b)(6) 2016 not to indicate that the pump was adjusted in any way. No further complication was reported.
 
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter. Product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer and company representative regarding a patient receiving dilaudid and bupivacaine via an implanted pump. Per the patient, there had always been dilaudid in the pump. They added bupivacaine after, but she wasn't sure which year. She didn't remember the dose or concentration. Per the patient, the pump was filled with ¿mostly concentrated dilaudid and only a little bupivacaine to try to numb it; it wasn't a lot¿. The patient was taking unspecified concomitant medications besides having the pain pump. The indication for pump use was non-malignant pain. On 16-(b)(6) 2018 it was reported that the patient had trouble with her device from the time she had it implanted until she had it removed. Per the patient, she had to beg to have the device removed and she was not happy with the treatment she received from her doctor and had filed complaints. Sometime after implant, the doctor had to manually flip the patient¿s pump. The patient stated that she was overweight and the device was put ¿in my flub¿. They put it in a roll, so she thought that was what happened because if she bent wrong, it would stick out funny and she would mas sage it back down because it was very painful because it was only under the sub-dermal layer. Every year, once a year, she had the thing revised to try to get it to stop doing that. On (b)(6) 2016, the patient went to have the pump filled and again it had flipped. They accused her of flipping the device, but she stated that she never in her entire life touched the thing. When they flipped her pump at the visit on (b)(6) 2016, she felt a pinch in her spine and a burning sensation. They then refilled the pump. The patient assumed this was when they pulled the catheter out of her spine, twisted up the tubing, and kinked the catheter. The popping sound was the releasing of the catheter and the patient getting all of that which resulted in the patient being overdosed from the pump and she ended up suffering a tbi (traumatic brain injury). The patient told them she should have an x-ray. She told them she didn't feel right; something in her back didn't feel right, it pinched and was burning really bad. Her doctor told her they were not going to do an x-ray. She was lethargic and not acting right after the appointment. Over the remainder of the month of (b)(6) 2016 she got worse. In the middle of (b)(6), she fell asleep in a bowl of cereal and almost drowned stating ¿that¿s how bad it got¿. She ended up in a coma-like state for 8 days. Per the patient, she was ¿drooling and incapable of doing anything¿. Even her primary care physician remembered her coming in on the (b)(6) and she wasn't acting right; she was lethargic and not acting right. Her speech started slurring like she was intoxicated the whole month of september. She remembered doing nothing for the whole month. On (b)(6) her mom picked her up to have her j-tube removed and her mom had to wash her face, brush her hair, dress her, and put her shoes on. When her j-tube was removed, she felt a lot of pressure; it was a painful procedure a lot of pressure went through her body with it. She was lying on a bed and heard a ¿ginormous pop¿ on the side that the pump was on even the nurse heard it. She screamed in pain and then all of a sudden passed out. The only thing she remembered was the (b)(6) lying on a table and feeling excruciating pain on her side where the pump was. She didn't remember coming home; didn't know how she got home or how she got out of the surgery center; didn't remember walking or talking; she was wheeled out; she didn't remember any of it. On tuesday ((b)(6) 2016), her aunt and her mom carried her to the car and brought her to a clinic and a nurse practitioner stated that ¿she seems like she¿s suffering from a slight overdose and should be fine by tomorrow and if not call the office¿. The patient¿s mom called 3 times and left 3 messages, but no one returned her calls. She was in a coma-like state and didn't remember anything until she finally snapped out of it on (b)(6). At one point in time, the patient remembered her husband slapping her face. Her dad and family/friends were fighting because they didn't know what to do with her because they thought she was dying. Per the patient, since (b)(6) she suffered with a tbi; didn't leave the house for 3 months; had severe anxiety that she didn't have before; she had manic breakdowns; couldn't go to kid¿s games; and couldn't even go to (b)(6) without having a panic attack. The patient felt that her life was ruined. She tried having a birthday party for her son and had a panic attack so bad that it threw her into an epileptic seizure. When she woke out of the stupor she didn't know she had a (b)(6) year old and on top of that had to learn to talk again. Her mom took her to see her regular doctor in (b)(6) 2016 and she started sweating and shaking in the car and couldn't breathe. In (b)(6) 2017, she had a manic episode that was when she truly found out they never fixed the pump and her doctor demanded that she come in, so her husband left work to bring her in. When she got there, she was told that her pump wasn't working since (b)(6). In (b)(6) of 2016, per the patient, her spine was cut into for no reason. When she had surgery in (b)(6), they were just moving the pump to prevent it from flipping, but they also cut into her spine to try and fix the catheter which they never did, so they ¿cut her body wide open¿. She was hyperventilating in the recovery room and was already having severe panic attacks. Her primary care physician had diagnosed her with a tbi because they had done mris and psychological exams and ¿all that stuff¿ and stated that she had all the signs and symptoms of a tbi, but ¿didn't show up in her brain because it¿s all in adipose tissue¿. Following the manic episode in (b)(6), her psychologist was contacting her pump managing physician asking what was going on with the pump. Per the patient, she had memory loss which started after (b)(6) when her pain pump malfunctioned. The patient had the device system explanted on an unspecified date. Additional information was received from a company representative who reported that a catheter revision was done on (b)(6) 2015 and pocket revisions were done on (b)(6) 2016. Per this reporter, the patient¿s therapy was fine as far as they remembered. No further complications were reported/anticipated.
 
Manufacturer Narrative
Device code (b)(4) no longer applied. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7211715
MDR Text Key103344352
Report Number3004209178-2018-01168
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received03/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/18/2014
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: 01/23/2018 Patient Sequence Number: 1
-
-