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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Diarrhea (1811); Vomiting (2144); Malaise (2359); Electric Shock (2554)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 21-sep-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported the leads went bad/were defective and her surgeon wanted to replaced the leads.The patient reported the ¿thing¿ shocked her and it was a serious adverse event.The patient stated her device was still shocking her even though the hcp disconnected one lead.The patient stated she told the hcp about the shocking and fixed it on (b)(6) 2018 but even after the hcp did the endoscope and adjusted the settings the device was still shocking her.The patient noted she had diarrhea for 3 days and was throwing up for 6 days so she had been sick for 9 days.The patient stated the manufacture representative (rep) was refusing to send the replacement lead so her hcp couldn't do the scheduled surgery on (b)(6).The patient stated that the reason for refusal was the patient¿s insurance ¿requires a referral¿ and the patient saw a denial paper.The patient noted the lead issues began in (b)(6) 2018.The patient noted they notified the rep of the lead issue on (b)(6) 2018.Additional information from the rep on (b)(6) reported they spoken with the patient and the hcp¿s office and the patient was scheduled for surgery on (b)(6).There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).It was reported her leads kept shocking her to the point she was having diarrhea.It was noted the patient was transferred to patient services.There were no further complications that have been reported as a result of this event.

Manufacturer Narrative

Device code c53269 no longer applies to this event.D7 pertains to lead enterra gastro 35cm ((b)(4)) and lead enterra gastro 35cm ((b)(4)).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare professional (hcp) rep via a manufacture representative (rep).The hcp clarified what was meant by the lead being ¿bad and defective¿ was the patient felt intermittent shocking when the device was turned on, the cause could not be determined until her scheduled procedure on (b)(6).The hcp stated the lead were still in the patient, but they could have them returned for analysis.The leads would be explanted on (b)(6).There were no further complications that have been 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 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: 7915683
• MDR Text Key: 121994592
• Report Number: 3004209178-2018-21711
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2018

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: 03/14/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 09/25/2018; 09/27/2018
• Supplement Dates FDA Received: 09/28/2018; 10/12/2018
• Date Device Manufactured: 09/15/2017
• 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