MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Premature Discharge of Battery (1057); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927)

Patient Problems Nausea (1970); Paresis (1998); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Malaise (2359); Electric Shock (2554)

Event Date 02/27/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial (b)(4), implanted: (b)(6) 2005, product type: lead.Product id: 435135, serial (b)(4), implanted: (b)(6) 2005, product type: lead.The main component of the system.Other relevant device(s) are: product id: 435135, (b)(4), ubd: 14-apr-2007, (b)(4); product id: 435135, (b)(4), ubd: 14-apr-2007, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient¿s gastroparesis symptoms started returning; they were getting really sick again and their nausea was so bad they had been bed ridden.It was noted that these symptoms came with a gradual onset.They went to their healthcare professional (hcp) who checked the implanted neurostimulator (ins) and tried several times, but the clinician programmer got ¿absolutely nothing¿ and the hcp told the patient the ins battery was dead.They were perplexed because their last ins lasted around eight years and this battery only lasted 4.5 years when they were on the same settings.Throughout the life of the device, the patient had experienced ¿zaps¿ here and there, noting they weren¿t adverse zaps, but more of a stimulation sensation that they felt when the device was working.They hadn¿t felt any zaps when their symptoms were returning but, a few days prior to the report and after the hcp told them the ins was dead, they felt the stimulator zap them and felt a current-like sensation go across their abdomen like they used to feel.They felt this while they were in their backyard and they didn¿t think they were around any electromagnetic sources.The patient was also worried their lead had moved or something, noting they had a procedure done where 90% of their colon was taken out so their body was shaped differently and they were worried the lead may have been affected during the procedure.The patient was redirected to their hcp to report the shock, to discuss battery replacement, and to check the lead for the suspected issues.No further complications were reported or anticipated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7859615
• MDR Text Key: 119658461
• Report Number: 3004209178-2018-20186
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/10/2018

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: 05/28/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/10/2018
• Date Device Manufactured: 12/13/2013
• 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: 54 YR