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

Model Number 3116

Device Problems High impedance (1291); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Electric Shock (2554)

Event Date 05/01/2017

Event Type  Injury  

Event Description

A manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that one of the fellows at the hcp office checked the patient's impedance and noticed that it was greater than 5000 ohms.That was about a month prior to the report and the therapy was turned off.The rep checked the impedance on the day of the report and it was at 784 ohms.An x-ray was taken and the lead looked intact, no fractures or kinks.The surgeon believed it was the implantable neurostimulator (ins) battery that was the issue.The patient was also feeling shocking sensations at the lead and ins site.It was reviewed with the hcp that there might be a loose connection in the header block and fluid got in.The impedance may have been changing due the lead making the connection at times and coming loose.The hcp was going to revise the implant on the day of the report.The ins was replaced and the impedance was at 566 ohms.It was unknown if the replacement resolved the shocking, however the patient would follow up in 30 days and everything was fine with the impedances.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A manufacturing representative (rep) reported that the patient was experiencing shocking.Impedances were run and c2 and c3 pairs were >200000 ohms, however the implantable neurostimulator (ins) was not in the pocket.The rep was going to have the hcp put it back in the pocket and rerun impedances.No further complications were reported.(b)(6) 2017 (b)(4) (rep): additional information received reported that the patient was experiencing shocking prior to their surgery, the battery was 8 years old.The patient¿s healthcare provider replaced the battery intraoperatively and the impendence was within range.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the hcp reported the connector was not significantly tight, there could be fluid in the lead area.No further complications were reported/anticipated.

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.

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 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: 6667317
• MDR Text Key: 78399155
• Report Number: 3004209178-2017-13712
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/24/2017

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: 09/28/2010
• 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: 06/06/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 07/03/2017; 07/25/2017; 07/21/2017; 08/01/2017; 08/01/2017
• Supplement Dates FDA Received: 07/11/2017; 07/25/2017; 08/03/2017; 08/24/2017; 10/05/2017
• Date Device Manufactured: 04/02/2009
• 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
• Patient Weight: 64