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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 Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 10-dec-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 morphine (2mg/ml at 0. 5mg/day) via an implantable pump for non-malignant pain and chronic low back pain. It was reported that patient was scheduled for normal eri/eos (elective replacement indicator/end of service) pump replacement today. When they opened the pocket it was observed that the catheter was completely severed. The catheter was noted to be very twisted. New pump placed and 8784 added, the physician tried to aspirate from the cap (catheter access port) but did not get successful csf aspiration. The physician stated that patient would need a dye study. During pre-op patient stated that the therapy was working well. Their managing physician had begun decreasing therapy a bit prior to this scheduled replacement.   the pump had been flipping and the physician had always been able to flip it back and access it in clinic. Plan for today was to create a new pocket which was successful.  originally the physician had completed a back table prime, and planned to keep daily dose the same at 0. 5mg/day. But with the severed catheter observed they decided to run the pump at lowest dose possible which was 0. 0961mg/day. The issue was not resolved at time of this report, patient status was alive no injury.  .
 
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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 Key13937807
MDR Text Key288108486
Report Number3004209178-2022-03903
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,Followup
Report Date 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2015
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: 03/29/2022 Patient Sequence Number: 1
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