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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 Migration or Expulsion of Device (1395)
Patient Problems Emotional Changes (1831); Pain (1994); Distress (2329); Sleep Dysfunction (2517); Insufficient Information (4580)
Event Date 03/01/2022
Event Type  Injury  
Event Description
Information was received from a consumer regarding a patient receiving morphine and a ¿muscle relaxer¿. The indication for use was chronic low back pain and non-malignant pain. The patient reported the pump has flipped and the patient has to have revision surgery and ¿it was causing severe pain¿. The patient stated they are getting "no relief" and are having to take oral morphine, stating they were up almost all night because of it and were "in tears the biggest part of the night". The pain is beginning to be every day. The patient stated 3 weeks ago, one doctor who saw the patient "put me down that it needs to be replaced asap, but i'm still suffering". Per the patient, their current managing physician was unavailable to do the surgery and was upset because there was no one else at the clinic that would perform the surgery. The patient requested physician listings.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key14012398
MDR Text Key288583932
Report Number3004209178-2022-04247
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 Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/13/2021
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: 04/05/2022 Patient Sequence Number: 1
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