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

Model Number 37800

Device Problems Break (1069); High impedance (1291)

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

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that during surgery, the physician cut the polypropylene portion of the lead and checked the impedances but they were ¿too high¿, so they consequently had to use a new lead.No patient symptoms were reported.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Product id: 4351-35, serial# (b)(4), product type: lead; product id: 4351-35, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported that the hcp prematurely cut the leads about a cm past the electrode and started suturing the leads in prior to initial impedance check, there was no way to move the leads because the needles had been removed when the polypropylene was cut.It was noted that this was a surgeon error and had nothing to do with the leads or neurostimulator.The hcp and manufacturer representative discussed the issue on the day it occurred and agreed that the impedance should have been checked prior to cutting the polypropylene and removing the needle.It was noted that replacing the leads resolved the high impedance.No further complications were reported/anticipated.

Manufacturer Narrative

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

• 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: 7670704
• MDR Text Key: 113798183
• Report Number: 3007566237-2018-02026
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

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: 09/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 07/10/2018; 07/10/2018; 08/08/2018
• Supplement Dates FDA Received: 07/10/2018; 07/10/2018; 10/04/2018
• Date Device Manufactured: 04/10/2018
• 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: 62 YR