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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 Problems Electromagnetic Interference (1194); Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a healthcare provider (hcp) and a consumer via a company representative regarding a patient receiving morphine (40 mg/ml at 17 mg/day) and bupivacaine (40 mg/ml at 17 mg/day) via an implanted pump. The indication for pump use was malignant pain. It was reported that the patient¿s pump was intermittently stalling and recovering. Per the pump logs, there were a number of relatively short duration motor stalls with motor stall recoveries noted soon after. The patient was still able to use his ptm (personal therapy manager) to get boluses and reported no problems with the therapy. He was in hospice with stage 4 cancer. The reporter was advised to inquire about any possible emi (electromagnetic interference) or magnetic sources in the environment and eliminate them if possible. Additional information was received on (b)(6) 2021 from the patient via the company representative who reported that the patient was advised to avoid placing anything over his pump that could potentially cause a motor stall. The patient stated that he may have placed his iphone 7 over his pump at times and had placed his cadd pump over his implanted pump at times as well. The patient had previously reported that the pump made noises and his ptm showed a code 100 (motor stall) and he had heard his pump alarm a few times since then but there were no more error messages when using the ptm.

 
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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 Key11819385
MDR Text Key250641892
Report Number3004209178-2021-07654
Device Sequence Number1
Product Code LKK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/13/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received05/13/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/09/2020
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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