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

Model Number 37800

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Burning Sensation (2146); Electric Shock (2554)

Event Date 04/07/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# unknown, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: unknown, (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 issues.It was reported that one of the leads was no longer attached, which was diagnosed last week, and the patient was being ¿shocked¿ internally.It was noted that the doctor tried to shut the lead wire off, but the ¿zapping got worse¿, so they turned it back on, and since the day after turning stimulation back on, the patient was getting shocked every 3-5 seconds and it was worse when the patient was moving.The patient did not know how long they could handle the ¿burning sensation inside¿.The patient was redirected to a healthcare provider (hcp) regarding their symptoms.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 4351-35, serial# unknown, 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 a surgeon would be performing revision surgery on the patient in the coming weeks.No date was available at the time of the report.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, 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 a surgeon would be performing revision surgery on the patient in the coming weeks.No date was available at the time of the report.No further complications were reported/anticipated.

• 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: 8537763
• MDR Text Key: 142784842
• Report Number: 3004209178-2019-08002
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• Date Device Manufactured: 12/05/2017
• 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: 44 YR