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

Model Number 7425G

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2002, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2002, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2002, product type: lead.(b)(4).

Event Description

A healthcare provider (hcp) via a manufacturer representative reported after the patient's initial implant she later had bowel surgery where the original implanting surgeon cut her lead or leads.The hcp implanted another lead or leads and left the remaining leads sutured into the stomach.It was unknown of the cut leads were capped or not.Indication for use was reported as gastric stimulation.If additional information is received, a follow-up report will be sent.

Event Description

Additional information received from the health care provider (hcp) reported they implanted other leads, possibly pain leads, as a result of mistakenly cutting the leads.The cut leads were left in the stomach wall.

Manufacturer Narrative

Device code (b)(4) no longer applies to the event.

Event Description

Additional information received from the manufacturer representative reported that they planned on removing their leads sometime in may as well as replacing with new leads and a new battery.

Event Description

Additional information received from the health care provider (hcp) via a manufacturer representative reported that the patient had surgery on (b)(6) 2016 to replace their leads and implant a new battery.The patient's leads actually had pus around them in the pocket where they were buried in the abdomen, so they were unable to replace the stimulator.They removed all the old wires and did a "toupe fund implication" and would follow-up in 6 to 8 weeks for replacement.Additional information received from the manufacturer representative reported that the patient was implanted with new leads and a new battery on (b)(6) 2016.

• 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: 5124657
• MDR Text Key: 27663129
• Report Number: 6000032-2015-00178
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup
• Report Date: 08/22/2016

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: 10/14/2003
• Device Model Number: 7425G
• Device Catalogue Number: 7425G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2016; 05/16/2016; 08/22/2016
• Date Device Manufactured: 04/23/2002
• 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): Required Intervention
• Patient Age: 00058 YR