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

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Impedance Problem (2950)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported the patient had a loss of therapeutic effect.The patient went to their healthcare provider¿s office the day of report with a return of symptoms.The patient stated they were hospitalized for this before but no one checked out the settings.The patient¿s device was set at 5 volts at the time of report and the patient stated that at their last visit they had been programmed to 7.8 volts and had been therapeutic at that level.The patient noted their return of symptoms started two weeks prior to report.The impedances were greater than 800 ohms and therefore it would not autocalculate and the health care provider was trying to determine what to set the voltage at.The patient¿s battery was at greater than 120 months.A longevity calculation indicated 22.09 months at a 7.8 volt reading factoring in that voltage being used since implant, however it had not been at 7.8 volts since implant.The patient started out at 3.3 volts in (b)(6) and had increased to 3.9 volts by (b)(6).The device impedance measurements recorded the day of report, in (b)(6), were all within normal range.Though, it was noted that the impedances had risen 150 ohms over time.The patient was reprogrammed at 7.8 volts as that was the last therapeutic setting.It was stated that the manufacturer representative was suspicious of lead migration due to the 150 point shift in impedances and x-rays and further testing was suggested to verify lead migration issues.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4166944
• MDR Text Key: 4788304
• Report Number: 3004209178-2014-19544
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/22/2014

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: 06/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/13/2014
• Date Device Manufactured: 12/17/2012
• 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): Hospitalization
• Patient Age: 00031 YR