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

Model Number 3116

Device Problems Pocket Stimulation (1463); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Foreign Body Reaction (1868); Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Cramp(s) (2193); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/27/2014

Event Type  Injury  

Event Description

Additional information received reports the patient had shocking sensation at implant site.Patient indicated that the lead wire and ins (stimulator) has to be removed and sent back for analysis.The patient and her doctor agrees that only the ins needed to be replaced.She doesn't want the lead wire replaced as well because it will cause her too miss work.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

Event Description

It was reported that the patient had a shocking sensation.It was noted that the minor shocks through the patient's gastric stimulator did not hurt but caused the muscle to spasm, happened a lot and lasted for 10-15 minutes at a time.It was noted that when the stimulation was at 5 v it was on and off, but when they increased it to 6 v, it happened all the time for the five days prior to the report.No outcome was provided with this event.Further follow up is being conducted to obtain this information.A supplemental report will be sent if additional information is received.

Manufacturer Narrative

(b)(4).

Event Description

Additional information reports there was not a fifty percent or greater symptom reduction.The stimulator and the lead was involved in the reported event.The device was turned off.The device was turned off and the patient was scheduled to return on (b)(6) 2014.The cause of the even was not determined and it was unknown if it was device related.Patient outcome was unknown because patient was scheduled for follow-up on (b)(6) 2014.Office visit notes the patient developed cramping and shocking seat.The pacer was turned off to discern if shocking sensation was a result of gastric stimulator.The device was interrogated with no changes in impedance from prior evaluation.The stimulator was shocking the abdominal wall when she turns to her left.Impedance was noted at 566 ohms.The patient was still having concerns regarding their device or therapy but was working with their healthcare provider or manufacturer representative.It was noted that the patient appointment was scheduled for (b)(6) 2014.

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.

Manufacturer Narrative

Other applicable components are: product id 4351-35 (b)(4), implanted: (b)(6)2014, explanted: (b)(6)2015, product type lead product id 4351-35 (b)(4), implanted: (b)(6)2014, explanted: (b)(6)2015, product type lead device code (b)(4) was removed as it does not apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional review indicates information reported previously in manufacturer's report (mfr) # 3007566237-2017-05312 about the shocking pertains to this manufacturer¿s report #.Any additional information related to the shocking will be reported under this mfr#.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

Additional information was received.It was reported that it didn't help with motility.It helps with the nausea.The electrical impulses will hemp the stomach to mimic slight digestion.Great for nausea.Unfortunately, patient's body rejected it and they can't use it.It did help a lot and they wish they had it back because it worked really well.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 4184966
• MDR Text Key: 5645910
• Report Number: 3004209178-2014-19990
• Device Sequence Number: 1
• Product Code: LNQ
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2023
• Date Device Manufactured: 05/01/2014
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00039 YR
• Patient Sex: Female