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

Model Number 37800

Device Problems Break (1069); Degraded (1153); High impedance (1291); Unstable (1667); Material Deformation (2976)

Patient Problems Pain (1994); Twiddlers Syndrome (2114); Complaint, Ill-Defined (2331); Cognitive Changes (2551)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be submitted when analysis is completed.The main component of the system and other applicable components are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that the patient was implanted originally on (b)(6) 2016 and did well with therapy symptom relief.A few weeks ago, the patient¿s device was interrogated, the leads were ¿out of range¿, and an out of range impedance message was received.During a surgical pocket investigation, the leads were discovered to be loose and twisted, and battery acid had leaked into the patient.Additional information was received on (b)(6) 2018.It was reported that there was extreme braiding of the lead wires, which typically happened when a patient was flipping their device in the pocket, and the high impedance message was over 800 ohms.It was noted that the gastroenterologist reported the patient may have some psychogenic challenges.Regarding the battery acid leaking from the device, it did not appear to have come from the device; however, there was a dark, almost gelatinous looking material under the pocket site and it was unknown where this came from.Biopsies were sent to pathology and the surgeon did not say there appeared to be any infection.Additional information was received on (b)(6) 2018.It was noted there were twisted leads and breakage, and the device was leaking and there was a breakdown of the protective coating which led to an erosion of the generator wall/casing.The patient had pain at the generator site.It was noted that the patient recovered without sequelae.No further complications were reported/anticipated.

Manufacturer Narrative

Product id (b)(4).Serial# (b)(4) implanted: (b)(4) 2016 explanted: (b)(4) 2018 product type lead product id (b)(4) serial# (b)(4) implanted: (b)(4) 2016 explanted: (b)(4) 2018 product type lead analysis of the implantable neurostimulator (ins) (serial # (b)(4) ) revealed that there was good stable output on all electrode pairs, telemetry was acceptable, and the ins passed functional testing.Analysis of the lead (serial # (b)(4) ) revealed that the outer insulation of the lead was twisted, the conductor wire was broken 8.2 cm from the proximal end, and the distal end was not returned.Analysis of the lead (serial # (b)(4) revealed that the outer insulation of the lead was twisted and the distal end was not returned.Electrical testing of the lead determined that continuity was complete.Fdccodes: (b)(4) fdmcodes: (b)(4) fdrcodes: (b)(4) pertain to product id (b)(4) serial# (b)(4) product type implantable electrical stimulator fdccodes: (b)(4), fdmcodes: (b)(4) fdrcodes:(b)(4) pertain to product id (b)(4) serial# (b)(4) product type lead and product id (b)(4) serial# (b)(4) product type lead.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 4351-35, serial# (b)(4), product type: lead and product id: 4351-35, serial# (b)(4), product type: lead.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.

Event Description

Additional information was received.It was reported that the device actually ruptured the patient¿s skin.The system was removed completely due to lead breakdown due to excessive twisting of the leads and erosion of the implanted neurostimulator (ins).

• 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: 7286605
• MDR Text Key: 100643963
• Report Number: 3004209178-2018-03712
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/05/2018

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: 05/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 04/05/2018; 05/14/2018; 06/01/2018
• Supplement Dates FDA Received: 04/09/2018; 05/14/2018; 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2015
• 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: 40 YR