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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 Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Overdose (1988); Pain (1994); Increased Sensitivity (2065); Burning Sensation (2146); Numbness (2415)
Event Date 02/12/2018
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 dilaudid (4. 0 mg/ml at 3. 1548 mg/day), bupivacaine (30. 0 mg/ml at 23. 661 mg/day), compounded baclofen (200. 0 mcg/ml at 157. 74 mcg/day), and clonidine (200. 0 mcg/ml at 157. 74 mcg/day) via an implanted pump. The indication for use was spinal pain. It was reported the patient had shortness of breath and increased pain on (b)(6) 2018. The clinical diagnosis was it medication side effects. The patient presented to the emergency department with lower extremity numbness on (b)(6) 2018. The next day therapy was suspended via magnet while in the hospital at 00:10. Later that afternoon, the patient reported burning pain had improved. The healthcare provider attributed this to either hyperalgesia or over-medication of bupivacaine. Therapy was resumed and daily rate was decreased 50%. On (b)(6) 2018, the patient had upper extremity numbness. The patient was examined, on (b)(6) 2018, and revealed increased radicular numbness. The patient's it rate was decreased by 33% and discussed catheter revision. The next day the patient had increased tingling following ptm activations. On (b)(6) 2018, the patient had uncontrolled pain secondary to it rate decreases due to side effects. The it rate was decreased again and started extended release morphine. On (b)(6) 2018, the pain had improved and side effects had resolved. The patient declined catheter revision. It was indicated the event was related to the device or therapy and related to the drugs hydromorphone, bupivacaine, clonidine, and baclofen. The event resulted in in-patient hospitalization. The issue resolved without sequelae on (b)(6) 2018. Additional information reported the hospitalization was a result of the reported event. The ca use of the burning pain was unknown. The patient's baseline weight was (b)(6).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7671768
MDR Text Key113503670
Report Number3004209178-2018-15342
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169508156
UDI-Public00643169508156
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
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/28/2018
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/06/2017
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: 07/09/2018 Patient Sequence Number: 1
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