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

Model Number 3116

Device Problems High impedance (1291); Overheating of Device (1437); Low Battery (2584)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Burning Sensation (2146)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A caller reported she was called to case for further troubleshooting and implantable neurostimulator replacement.The consumer was complaining of nausea since (b)(6) 2016, along with high impedance readings.Impedance was a follows: c0, c1,01, 02, 03, 12, and 13 all = >4k ohms, c2=456 ohms, c3=2417 ohms, and 23=2417 ohms.The physician after finding high impedance, causing frequent overheating, turned stimulation off.Since the device had been off, the consumer was having frequent nausea, vomiting, and abdominal discomfort.No falls were noted as related to the issue.The caller noted being ready to go into the or.The caller noted that consumer¿s device lasted three years and was wondering if this current device was burning the battery faster.Estimated longevity was end of service (eos) at 3.6 years based on 2.9v/330pw/55hz.3+2- cycling 2 second on and 3 second off.Indication for use included gastric stimulation.Additional information received from the representative reported the ins was replaced.The lead was not addressed since impedance tested fine after the ins was replaced.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis findings showed good stable output on all electrodes.There were no issues when pressing on the ins can.Telemetry was acceptable.Visual inspections showed that the connector module was scratched and the shield/can was scratched.No abnormal hotspots were observed and there was no evidence to suggest the complaint device behaved out of specifications.It was noted that the battery was not in a new condition.A good faith effort will be made to obtain the applicable information relevant to the report.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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6211749
• MDR Text Key: 63472333
• Report Number: 3004209178-2016-27372
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2017

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: 04/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 03/21/2017; 03/21/2017
• Supplement Dates FDA Received: 01/24/2017; 03/29/2017; 09/28/2017; 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2014
• 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: 29 YR