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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ENTERRA; INTESTINAL STIMULATOR
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MPRI ENTERRA; INTESTINAL STIMULATOR Back to Search Results
Model Number 4351-35
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/21/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the operating nurse was prettying a suture onto the lead prior to implant and accidental cut the prolene suture on the lead.It was never inside the patient.They had to toss it and open another lead. no further complications were reported.
 
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Brand Name
ENTERRA
Common Device Name
INTESTINAL STIMULATOR
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key11166961
Report Number2649622-2021-00856
Device Sequence Number14356612
Product Code LNQ
UDI-Device Identifier00643169936577
UDI-Public00643169936577
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
H990014
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/13/2021
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
Operator of Device Health Professional
Device Expiration Date11/11/2022
Device Model Number4351-35
Device Catalogue Number4351-35
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/21/2020
Initial Report FDA Received Date01/13/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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