MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.

Event Description

A manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that the implantable neurostimulator (ins) was being replaced due to a normal battery depletion.The new ins was hooked up to the lead and impedance of >20,000 ohms was seen (captured in a separate event).A second ins was tried and they were still seeing high impedances.The rep stated they did not think this was an ins issue and was more of a lead issue.The plan, moving forward, would be to change out the leads.The hcp would retain the 2nd ins and use that at the lead replacement surgery.The date of the surgery was unknown at the time of the report.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the rep reported that the patient experienced a return of symptoms with the event.A revision was scheduled for (b)(6) 2017.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the rep indicated that the revision was completed and everything worked.They stated that the original leads were bad.The second ins was implanted and the new leads worked.There were no further complications reported as a result of this event.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6699324
• MDR Text Key: 79642218
• Report Number: 3007566237-2017-02758
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/01/2017

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: 11/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 07/14/2017; 09/01/2017; 09/01/2017
• Supplement Dates FDA Received: 08/03/2017; 09/01/2017; 09/01/2017
• Date Device Manufactured: 05/15/2017
• 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: 50 YR
• Patient Weight: 83