Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESHAPE LIFESCIENCES MAESTRO RECHARGEABLE SYSTEM; ANTERIOR & POSTERIOR LEAD
  • 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
 

RESHAPE LIFESCIENCES MAESTRO RECHARGEABLE SYSTEM; ANTERIOR & POSTERIOR LEAD Back to Search Results
Model Number P01363-001
Device Problem High impedance (1291)
Patient Problems No Consequences Or Impact To Patient (2199); Therapeutic Response, Decreased (2271)
Event Date 12/11/2019
Event Type  malfunction  
Event Description
The patient was extremely disappointed with therapy and when interrogating the device, a lead issue came up stating, the "posterior tip to ring circuit open." however, the patient was able to feel a sensation of therapy during a real test set at 7.0m.A.The reshape field specialist adjusted the patient's setting to 4.50m.A.The patient continued to receive therapy following the adjustment.
 
Event Description
The patient was extremely disappointed with therapy and when interrogating the device, a lead issue came up stating, the "posterior tip to ring circuit open." however, the patient was able to feel a sensation of therapy during a real test set at 7.0m.A.The reshape field specialist adjusted the patient's setting to 4.50m.A.The patient continued to receive therapy following the adjustment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAESTRO RECHARGEABLE SYSTEM
Type of Device
ANTERIOR & POSTERIOR LEAD
Manufacturer (Section D)
RESHAPE LIFESCIENCES
2800 patton road
saint paul, mn MN 55113
MDR Report Key9560720
MDR Text Key198584730
Report Number3005025697-2020-00001
Device Sequence Number1
Product Code PIM
Combination Product (y/n)N
PMA/PMN Number
P130019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP01363-001
Device Catalogue NumberMAESTRO MODEL 2200P-47E
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/11/2019
Initial Date FDA Received01/07/2020
Supplement Dates Manufacturer Received12/11/2019
Supplement Dates FDA Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-