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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 Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Bradycardia (1751); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Overdose (1988); Tingling (2171); Dysphasia (2195); Cognitive Changes (2551); Lethargy (2560)
Event Date 09/20/2018
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 provider via a clinical study regarding a patient receiving fentanyl, bupivacaine, and clonidine via an implanted pump. The indication for use was non-malignant pain and failed back surgery syndrome. It was reported, on (b)(6) 2018, about two hours following a pump refill, the patient's (in a rehab facility, unrelated to device, implant/revision, or therapy) mental status was altered and they had difficulty speaking. The device diagnosis was other probably pump pocket fill and the clinical diagnosis was it medication overdose. Narcan was administered twice and the patient was transferred to the ed. Upon arrival, the patient was found to be hypotensive and bradycardic. The patient was lethargic but able to open their eyes and follow commands. The patient was started on a narcan drip, iv fluids, and fentanyl prn in the icu. On (b)(6) 2018, the it therapy was suspended via magnet over pump. Started hydralazine as needed for uncontrolled hypertension. On (b)(6) 2018, the pump was interrogated at the hospital and the magnet was removed to resume therapy. Therapy was suspended again via magnet secondary to sustained hypotension. The it rate was decreased and therapy was resumed. The patient was stable and discharged to a skilled nursing facility on (b)(6) 2018. The event resulted in in-patient hospitalization. It was indicated the event was related to the device or therapy. The issue resolved without sequelae on (b)(6) 2018.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a clinical study indicated the cause of the pocket fill/overdose was not determined. The patient's baseline weight was (b)(6) pounds. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare provider via a clinical study reported the patient was receiving fentanyl (400 mcg at 150. 17925 mcg/day). Bupivacaine (30 mg at 11. 26344 mg/day), and clonidine (450 mcg at 168. 95166 mcg/day) via an implantable pump.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a clinical study on 2019-jul-22. It was reported that the patient was hospitalized (in-patient or prolonged) on (b)(6) 2018 for an adverse reaction to their medication. The patient reportedly experienced slurred speech and upper extremity tingling on (b)(6) 2018. The clinical diagnosis was it medication side effects. Interventions included patient's pump therapy being suspended and resumed several times during the hospitalization via magnet. The therapy was suspended with a magnet on (b)(6) 2018, and twice on (b)(6) 2018. Therapy was resumed on (b)(6) 2018 and three times on (b)(6) 2019. The pump was then reprogrammed on (b)(6) 2018 where the pump was decreased. The etiology of the event indicated the relationship of the event to the device or therapy was possibly related and indicated the relationship of the event to the implant procedure was not related. The relatedness to the drugs (fentanyl, bupivacaine, and clonidine) was possibly related and the drug action that caused the event was no change in the drug. The outcome of the event was reported as unresolved at time of study exit/death/study closure. Additional information received indicated the outcome was death. It was noted that the death was not related to device, therapy, or procedure no further complications were reported.
 
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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 Key7905524
MDR Text Key121584416
Report Number3004209178-2018-21433
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/11/2016
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: 09/25/2018 Patient Sequence Number: 1
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