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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 Infusion or Flow Problem (2964)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2014, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 23-oct-2016, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving dilaudid (5mg/ml at 0. 24 mg/day) and bupivacaine (3 mg/ml at 0. 144 mg/day) via an implantable pump for non-malignant pain and failed back surgery syndrome. It was reported that the patient recently presented to the healthcare provider (hcp) office with complaints of worsening pain. A catheter access study was performed in clinic and the catheter was determined to be non-patent. The patient was seen in clinic several times following the negative catheter access port (cap) study to sequentially reduce their intrathecal dosing in preparation for a catheter revision. There were no external factors that contributed to the event. Diagnostics/troubleshooting included completing thoracic and lumbar x-rays on (b)(6) 2022 which showed the catheter at superior t6 level. Actions/interventions taken included taking the patient to surgery for catheter revision. Hcp opened the pump pocket and dissected out the catheter. The pump segment was removed and remained sterile on operating table. The hcp attempted to aspirate catheter again but there was still no return of fluid. They then flushed the intrathecal catheter with preservative free normal saline. There was initially some resistance, but after several flushes, the catheter began to freely drip cerebrospinal fluid (csf) and the hcp was able to easily aspirate. The proximal segment and pump were reattached to the spinal segment and the hcp again aspirated with positive return. The pump was placed back in the pump pocket and the incision was closed. The event was resolved at the time of the report.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14245248
MDR Text Key290444816
Report Number3004209178-2022-05420
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/23/2020
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: 04/28/2022 Patient Sequence Number: 1
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