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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 Problem Protective Measures Problem (3015)
Patient Problems Fever (1858); Muscular Rigidity (1968); Seizures (2063); Therapeutic Response, Decreased (2271); Irritability (2421)
Event Date 07/27/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the healthcare professional (hcp) via a manufacturer¿s representative (rep) regarding the implantable drug infusion device. The drug being delivered was 2,000 mcg/ml baclofen at 12 mcg/day. It was reported that the patient is in the hospital and the rep was called to interrogate the pump. Caller reported service code 87, safe state occurred. The patient experienced increased spasticity and seizures. The issue started on (b)(6) 2020. No other alerts or alarms noted in the logs. It was explained that the safe state could be electromagnetic interference (emi) related and an isolated event. It was then recommended that they reprogram the pump to the normal infusion rate. There were no further complications reported/anticipated.
 
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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 Key10356693
MDR Text Key201499673
Report Number3004209178-2020-13315
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received08/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/27/2018
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: 08/03/2020 Patient Sequence Number: 1
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