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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 8637-20
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2022
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 foreign healthcare provider (hcp) via a distributor's representative (dist. ) regarding a patient who was receiving 4 mg/ml of morphine at 1. 9476 mg/day and 6 mg/ml of bupivacaine at 2. 9215 mg/day via an implantable pump. On (b)(6) 2022, it was reported that a service error 100 (indicative of a motor stall) was detected during a pump service appointment. The hcp had stopped the pump for 24 hours, but when they attempted to restart the pump, the error code appeared. No external factors that might have caused or contributed to the issue. The logs provided showed an error code of 232 (also indicative of a motor stall), but no other issues were noted. Surgical intervention was scheduled for (b)(6) 2022. The issue was not considered resolved at the time of the report. The patient's status was listed as "alive - no injury". Additional information was received from a foreign hcp via a manufacturer representative and a distributor representative. The distributor representative went to the hospital on (b)(6) 2022 to check the pump. After synchronizing, they found no error message. They saw that the pump had restarted on (b)(6) 2022 at 12:26 pm. It was indicated the patient was well and had follow-up, and no health issues were found. It was decided to not change the pump and to keep the patient under medical supervision. A session report from (b)(6) 2022 was provided, indicating the pump was in a state of motor stall. A session report from (b)(6) 2022 was provided, indicating a motor stall recovery occurred on (b)(6) 2022 at 12:26 pm. Additional information was received. It was reported the pump stalled again on (b)(6) 2022 around 2:30 am. It was decided to replace the pump the week of (b)(6) 2022. The pump would be returned after replacement. Regarding the pump being stopped for 24 hours, this was a deliberate decision by the hcp.
 
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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 Key13929843
MDR Text Key288041027
Report Number3004209178-2022-03853
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2018
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2016
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: 03/28/2022 Patient Sequence Number: 1
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