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Table 1 Adverse Events related to the device, anti-reflux surgery or surgery in general

From: Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

Adverse Events during surgery and in the postoperative course up to 6 months Number of subjects
n (%)
Number of events
n
Full recovery with intact treatment effect
Number of Adverse Events (n = 50) 8 (16%) 11 YES
Device related adverse events (SADE or ADE) 0 0  
Surgical non-device related serious adverse events (SAE) 4 (8%) 6 YES
Severe
 Mediastinal abscess, empyema and abdominal abscess 1a 3 YES
 Intra-abdominal haemorrhage 1 1 YES
Moderate
 Pleuritis 1 1 YES
Mild
 Removal of foreign body (part of a needle from the abdominal wall) 1 1 YES
 Surgical non-device related non-serious adverse events (AE) 4 (8%) 5 YES
Moderate
 Abdominal pain and incisional hernia 1b 2 YES
Mild
 Accidental intra-operative instrumental hepatic lesion (small) 1 1 YES
 Post-op delayed gastro-intestinal paralysis (one day) 1 1 YES
 Procedural pneumothorax 1 1 YES
Adverse Events between 6 months and 1 yearc 1 (2%) 1 YES
Device related adverse events (SADE or ADE) 0 0  
Surgical non-device related serious adverse events (SAE) 1 (2%) 1 YES
Moderate
 Release of fundoplication sutures – successfully re-sutured 1 1 YES
  1. The analysis is based on 50 subjects, i.e. all subjects included in the safety analysis set
  2. a The events occurred in the same subject (caused by an infection unrelated to the device, which was unaffected in its enclosed pouch)
  3. b The events occurred in the same subject (a small hernia in the abdominal wall)
  4. c Four AEs of gastritis occurred in 4 subjects all with endoscopy verified gastritis and lack of esophagitis, all resolved