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Model Number P152030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Anemia (1706); Bacterial Infection (1735); Cellulitis (1768); Diarrhea (1811); Purulent Discharge (1812); Fever (1858); Fistula (1862); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Pneumonia (2011); Renal Failure (2041); Staphylococcus Aureus (2058); Scarring (2061); Sepsis (2067); Septic Shock (2068); Vomiting (2144); Weakness (2145); Discharge (2225); Injury (2348); Fasciitis (2375); Obstruction/Occlusion (2422); Respiratory Failure (2484); Ascites (2596); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced infection.Post-operative patient treatment included wound vac and mesh removal.
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a recurrent incisional hernia.It was reported that after retro rectus implant, the patient experienced infection, abnormal lab results (wbc, hemoglobin, neutrophils, albumin, calcium, lactic acid, creatinine, cortisol, lipase), inflammation, necrosis, abscess, esherichia coli, enterococcus, streptococcus viridans, lactobacillus, stenotrophomonas maltophilia, staphylococcus epidermidis, necrotic adipose tissue, septal cellulitis, neutrophils, anemia, increased airway pressure from loss of abdominal wall compliance and fluid overload, postoperative ileus, pain of surgical scar, redness, black spot, fever, diarrhea, vomiting, progressive weakness, nectrotizing fasciitis, sepsis, septic shock, hypotension, lactic acidosis, acute renal failure, greenish purulent drainage, enterocutaneous fistula, bilious drainage, fistula of intestine, pneumonia, acute respiratory failure due to chronic lung disease, infective myositis, and induration around wound.Post-operative patient treatment included wound vac, multiple procedures of excisional debridement under anesthesia for complicated abdominal wound, tracheostomy with post-op transfer to icu, and mesh removal.
Manufacturer Narrative
Additional information: a4, b5, b6, b7, d4(catalog#, model#, expiration date, lot#, udi), g4, g5(pma/510k), h6 h6:patient code- (b)(6) (lactic acidosis; infective myositis; induration; abnormal lab results; adipose tissue; neutrophils; increase airway pressue; redness; black spot) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Brand Name
Type of Device
Manufacturer (Section D)
victoria house, victoria road
aldershot, hampshire GU11 1EJ
GB  GU11 1EJ
MDR Report Key9663946
MDR Text Key177747076
Report Number9617613-2020-00025
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2013
Device Model NumberP152030
Device Catalogue NumberP152030
Device Lot Number09B2808
Was Device Available for Evaluation? No
Date Manufacturer Received01/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age43 YR
Patient Weight118