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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 8637-40
Device Problems Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problems Emotional Changes (1831); Overdose (1988); Pain (1994); Therapeutic Response, Decreased (2271); Distress (2329); Complaint, Ill-Defined (2331); Underdose (2542); No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2018
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 healthcare professional (hcp) via the manufacturer¿s representative (rep) regarding the patient¿s implantable drug infusion device. The drugs being delivered were 2. 5 mcg/ml prialt (ziconotide) at 1 mcg/day, 13. 2 mg/ml dilaudid (hydromorphone) at 5. 276 mg/day, and 1 ml/ml saline at 0. 4 ml/day. The reason for use was non-malignant pain. It was reported that the actual reservoir volume (arv) was less than the expected reservoir volume (erv) on (b)(6) 2018. The arv was 0. 5 and the erv was 8. 5. Troubleshooting performed prior to the call consisted of the reservoir being accessed, the catheter access port (cap) was aspirated, and the pump was filled with 20ml of ¿pfns. ¿ overinfusion was reviewed and it was also reviewed to monitor the patient and bring the patient back early to check the volume. There were no symptoms reported. There were no further complications reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer. It was reported that they took dilaudid out of the pump and put prialt in to see if it would help with the patient's nerve damage. The prialt did not work, so they replaced it with dilaudid. From june until september, the patient had been to the hospital and back, crying and saying something was wrong. They tried increasing the pump. The patient then asked the healthcare professional (hcp) to check the pump and there was "nothing there". It was noted the pump never alarmed and the patient had been "to hell and back". It was then stated that for three months the patient had no medication in the pump. At one point the patient felt like she was going to pass out and "felt like all the medication was pumped in her. It was stated that the patient was told twice the volume discrepancy was not significant. It was noted the pump was due to be filled at the end of (b)(6) and it was empty "probably the first of (b)(6)". It was stated the patient's life had been ruined by her disease and that this was the worst summer of her entire life and she was still suffering. The patient was not very happy and was sitting in the house 24/7. It was noted the medication in the pump was very low because they did not want to overdose her, which was why she was still suffering. It was stated the hcp was going to send the pump back for analysis. No further issues were reported or anticipated.
 
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 healthcare professional (hcp) via the manufacturer¿s representative on 2018-oct-30. It was reported that the pump was replaced on 2018-(b)(6). High residuals in the pump at refills were reported (note this contradicts with earlier reported information). The issue was considered resolved. The patient's weight was unknown. The patient's status at the time of the report was alive - no injury. 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 on 14-feb-2019 from the patient who reported that prior to the pump replacement she was in pain. She spent 3 months going to the er (emergency room) time after time. She stated that it had ruined her whole summer, she missed everything. She had gone a long time without medication, but finally went to the doctor and said, ¿please if you don't do something i don't know what i¿ll do with myself¿ and then the doctor found no medication in the pump. Week after week she was not getting medicine. She stated that she was ¿in pure hell¿ and if she didn't have the faith that she had she would have taken her life. The pain was beyond anything she had ever dreamed of. She had been repeatedly told that the numbers could be different each time from person to person or the person putting it in. The patient was disappointed and felt like no one did her any favors. No further complications were reported/anticipated.
 
Manufacturer Narrative
The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing. Visual inspection identified damage to the septum that resulted in a leak. Logs indicated that the drugs being delivered were 10 mg/ml hydromorphone at 0. 5 mg/day, 50 mcg/ml clonidine at 2. 498 mcg/day, and 2. 5 mg/ml bupivacaine at 0. 1249 mg/day. 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 received from the healthcare provider who reported that the patient had severe episodes of pain a few months prior to (b)(6) 2018. Volumes of pump showed discrepancies. The patient had over-infusion of pump medications, with resulting withdrawal and severe pain when the pump was empty. The malfunctioning pump was replaced in (b)(6) 2018. No further complications were reported or 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 Key7619735
MDR Text Key111864516
Report Number3004209178-2018-13852
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1570-2014

Patient Treatment Data
Date Received: 06/20/2018 Patient Sequence Number: 1
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