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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE LIFESCIENCES MAESTRO RECHARGEABLE SYSTEM; RECHARGEABLE NEUROREGULATOR
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RESHAPE LIFESCIENCES MAESTRO RECHARGEABLE SYSTEM; RECHARGEABLE NEUROREGULATOR Back to Search Results
Model Number 2002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 06/15/2018
Event Type  Injury  
Event Description
The physician reported patient (b)(6) had an rnr pocket infection.The physician treated the patient with antibiotics and they responded positive clinically; however, when the physician takes the patient off antibiotics, the infection flares up.Therefore, the patient and the physician decided to explant the device.
 
Event Description
The physician reported patient 835-arh had an rnr pocket infection.The physician treated the patient with antibiotics and they responded positive clinically; however, when the physician takes the patient off antiobiotics, the infection flares up.Therefore, the patient and the physician decided to explant the device.
 
Manufacturer Narrative
Device was never returned for evaluation.
 
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Brand Name
MAESTRO RECHARGEABLE SYSTEM
Type of Device
RECHARGEABLE NEUROREGULATOR
Manufacturer (Section D)
RESHAPE LIFESCIENCES
2800 patton road
saint paul MN 55113
MDR Report Key7691289
MDR Text Key114087478
Report Number3005025697-2018-00007
Device Sequence Number1
Product Code PIM
UDI-Device Identifier00857334004262
UDI-Public00857334004262
Combination Product (y/n)N
PMA/PMN Number
P130019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number2002
Device Catalogue Number2002
Was Device Available for Evaluation? No
Date Manufacturer Received06/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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