MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ENTERRA; INTESTINAL STIMULATOR

Model Number 7425G

Device Problems Display or Visual Feedback Problem (1184); Impedance Problem (2950)

Patient Problems Adhesion(s) (1695); Nausea (1970); Paresis (1998); Tachycardia (2095); Therapeutic Effects, Unexpected (2099); Vasodilatation (2127); Vomiting (2144); Electrolyte Imbalance (2196); Discomfort (2330); Test Result (2695); Constipation (3274)

Event Date 09/13/2001

Event Type  Injury  

Event Description

It was reported that the patient presented with a history of intractable nausea and vomiting secondary to gastroparesis, noting that he vomited approximately 30 times since it all began the friday before admission to the hospital.Physical examination found slightly dry mucous membranes and ¿tachy¿ cardiovascular.Laboratory results were unremarkable except for glucose at 246.The patient was placed on intravenous (iv) zofran and other medications to control nausea; he was also given medicine to control high blood pressure.Nausea and vomiting quickly resolved, so the patient¿s diet was advanced quickly as tolerated.Deemed medically stable, the patient was discharged on (b)(6) 2001.However, the device was reportedly ¿not functioning properly¿ so a kidneys ureters bladder (kub) test was ordered in order to check placement of leads.It was noted that the implantable neurostimulator (ins) was ¿malfunctioning¿ and there was a lead impedance issue as they were out of range.On last day of admission, device was checked with demonstrated increased impedance, although kub demonstrated proper placement of leads.Less than a week later, the patient began experiencing nausea and vomiting ¿likely¿ secondary to gastroparesis, stating he could not take any oral medications.The patient was admitted to the hospital on (b)(6) 2001 and had ¿no improvement¿ in his nausea and vomiting since placement.The patient also experienced constipation, mild tenderness of the abdomen, high resting pulse of 99, and elevated blood pressure of 190/119.A chest view was taken which showed mild prominence of mediastinum, secondary to vascular ectasia.It was noted that there was an adverse reaction and that impedances had become greatly elevated to the point that it was uncertain of ins connection to the lead.The leads ¿appeared¿ to be greatly stretched on the flat plate although they ¿did not appear that different on the flat plate than they were from the initial images.¿ the physician opted to perform an exploratory surgery and found that there were ¿several adhesions¿ and the lead had pulled out of the stomach wall.It was noted that the leads had ¿pulled out¿ from the plastic disks which were sewn to the anterior stomach wall; both leads were out of the stomach wall and held to the stomach by the ¿5-0 silk." the insulation sheath had fully covered the lead, most likely due to effect of pulling on the lead against the silk suture.The monofilament had pulled out of the clips on the plastic disks as well.It was noted that the ins was ¿not properly in place.¿ the adhesions were removed, mesothelial lining was removed, wound was revised, and leads were replaced due to "dislodgement" and "positioning difficulties." additionally, upon examination, the serial number was listed as ¿???¿ and the device was not correct as to how much time it had been on.Due to this and the concern that the ins was also malfunctioning, the ins was removed as well on (b)(6) 2001.The event ended (b)(6) 2001 and the patient recovered.Follow up has been conducted.If any additional information is received, a supplemental report will be sent.

Manufacturer Narrative

Product id: 4351, serial# (b)(4), product type: lead.Product id: 4351, serial# (b)(4), product type: lead.Product id: 4351, serial# (b)(4), product type: lead.Analysis of the implantable neurostimulator (ins) found no anomaly.The ins was "functionally ok" with a setscrew backed out too far, burn marks on titanium can/insulation coating, foreign material in connector ports, insulation coating was scratched, and "review after por done prior to product analysis." (b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4186467
• MDR Text Key: 16545488
• Report Number: 6000032-2014-00244
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2001

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2002
• Device Model Number: 7425G
• Device Catalogue Number: 7425G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2001
• Initial Date FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention