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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 01/25/2021
Event Type  Malfunction  
Manufacturer Narrative

The pump was reported to have been implanted in 2020. 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 manufacturer's representative regarding a patient who was receiving an unknown drug via an implantable pump for an unknown indication for use. It was reported a 15 minute motor stall occurred on (b)(6) 2021. It was indicated the patient had their bag on their lap with an (b)(6) in it. There was no repeat of the motor stall. There was no reported patient impact. Further complications were not reported. Additional information was received. It was indicated the patient had an (b)(6). At the time of occurrence, they did not have any [(b)(6)] accessories like a magsafe in their bag and there were no other magnetic devices. It was reported the patient was in their living room of their home at the time of the critical alarm. They had their purse/bag on their lap, which contained their (b)(4). They never put their phone on their pump, but because the bag was on their lap, the phone was probably close to the pump. There had been no repeat of a motor stall. It was indicated the patient lived at home, so provoking the alarm would not be feasible. The nurse practitioner instructed the patient not to keep the phone on or near the pump. The pump logs were checked. No further actions beside instructing the patient as previously described were taken. The issue was considered resolved. The patient status was alive - no injury. A session report from (b)(6) 2021 at 11:28 was provided. The pump was delivering compounded baclofen (2,000. 0 mcg/ml at 464. 7 mcg/day). The motor stall occurred on (b)(6) 2021 at 17:10 and recovered at 17:22. Additional information was received. The patient lived in their own home and was wheelchair-bound due to a spinal cord injury. The patient was at home at the time of the event, and there were no "special features" around them.

 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11386420
MDR Text Key233804611
Report Number3004209178-2021-03320
Device Sequence Number1
Product Code LKK
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberP860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2021
Device MODEL Number8637-20
Device Catalogue Number8637-20
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 Received01/29/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/08/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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