• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Cognitive Changes (2551); Insufficient Information (4580)
Event Date 09/01/2021
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 healthcare provider (hcp) and a company representative regarding a patient receiving duramorph (5 mg/ml at 0. 7304 mg/day) and marcaine (27. 6 mg/ml at 4. 032 mg/day) via an implanted pump. The indication for pump use was non-malignant pain. It was reported by the nurse practitioner that the patient was hospitalized today with hypotension, bradycardia, and was obtunded. The reporter believed the patient was getting too much intrathecal medication and they wanted the dose decreased. Per the reporter, the patient was seen 1 month ago at the hospital with similar symptoms, but not as significant and at that time they felt his dosing was too high and they discontinued his chlorthalidone. The patient had been routinely going in for dosing increases. Per the reporter, the patient took a lot of antidepressants, was also using ativan 0. 5 mg, and was on lasix. The emergency overdose procedure and emptying the reservoir were discussed and the reporter stated that theywould prefer to program the pump to a lower dose. Additional information was received from a company representative who reported that he was called to go to the icu (intensive care unit) because the patient needed his pump turned down. Per the reporter, he was in the hospital for other medical conditions. It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue. The pump dose was decreased by 15% per the physician. It was unknown if the issue was resolved, and it was indicated that the hcp had no further information to provide regarding the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12728225
MDR Text Key279287985
Report Number3004209178-2021-16201
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 Nurse Practitioner
Type of Report Initial,Followup
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/17/2021
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: 11/01/2021 Patient Sequence Number: 1
-
-