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

Model Number 37800

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

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

Event Date 11/22/2016

Event Type  malfunction  

Event Description

A manufacturing representative (rep) reported a defective screw on the replacement battery.The device was never implanted and the customer was supposed to return it for a new one.After the rep researched this, customer service learned that the they had not returned it as of yet.The expiration date to return it was (b)(6) 2017.The rep is working with the hcp to find out what happened and it was noted that the issue was not resolved.There were no patient symptoms reported.The implantable neurostimulator (ins) indication for use was not clear at the time of the report.

Manufacturer Narrative

(b)(4).

Event Description

Additional information from the healthcare provider (hcp) reported that with the screw driver part to be in place, it would not tighten down onto the lead.Almost like threads not matched up, other 3 were okay.The cause was unknown and they stated that the device was returned and they informed the rep.They noted that the device was never implanted in the body.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_wrench_acc, product type: accessory.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Product analysis (b)(4) :analysis information -- 2017-05-26 12:31:51 cst pli# 20 product id# 37800: analysis determined that the set screw on the implantable neurostimulator (ins) was backed out beyond the point of being able to engage with the connector block.Information references the main component of the system and other applicable components are: product id neu_wrench_acc lot# (b)(4) unknown implanted: explanted: product type accessory.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.

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 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6311735
• MDR Text Key: 66807206
• Report Number: 3004209178-2017-02815
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 05/26/2017; 05/26/2017
• Supplement Dates FDA Received: 02/17/2017; 02/17/2017; 04/25/2017; 06/20/2017; 09/29/2017; 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• 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 Age: 42 YR