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

Model Number 3116

Device Problems Intermittent Continuity (1121); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Tingling (2171); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that, while stimulation is turned on, the patient felt a shocking or jolting sensation.It was further reported that the patient felt a slight tingling and shocking sensation where the implantable neurostimulator (ins) was located.It was noted that this began ¿about a month ago.¿ the patient was reportedly getting good therapy and her therapy had not been affected since the tingling and shocking feeling started.It was noted that the patient also described the sensation at her ins as sometimes painful.The sensation reportedly occurred every 15 minutes it was later reported that the patient was scheduled for an appointment on the day following the report.It was later reported that the patient¿s impedances were greater than 4,000 ohms.It was noted, however, that the hcp was receiving impedance measurements in range on multiple programming sessions.The hcp was asked if everything had been tried and the programming parameters had been exhausted, and the hcp replied everything had been tried.It was further reported that the hcp had made the decision to revise the device.The device and leads were removed on (b)(6) 2014 and replaced with a new system.

Manufacturer Narrative

Product id 4351-35, serial# (b)(4), explanted: 2014 (b)(6); product type lead product id 4351-35, serial# (b)(4), explanted: 2014 (b)(6); product type lead.(b)(4).

Manufacturer Narrative

(b)(4): analysis of the implantable neurostimulator found that all grommets had a punch out hole.It was noted there were low impedances between the indifferent and #1 electrodes, between the indifferent and #2 electrodes, and between the #1 and #2 electrodes due to the punch out holes.Analysis of the lead ((b)(4)) found no significant anomaly.The tubing connected to the trumpet anchor was cut through.The lead was electrically ¿ok.¿ analysis of the lead ((b)(4)) found no significant anomaly.The tubing connected to the trumpet anchor was cut through.The lead was electrically ¿ok.¿.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient experienced a shocking sensation at the incision site and device pocket.It was unknown if action was required, but the patient was well and recovering therapy.This information was previously reported in manufacturer report # 3007566237-2014-03163; any new information will be reported under report # 3004209178-2014-03539 no further information was provided by the doctor about the patient and system, so additional information was requested.If additional information is received a supplemental report will be sent.**identical information was reported for both (b)(4), but pertained to two separate patients**.

• 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: 3645093
• MDR Text Key: 20107669
• Report Number: 3004209178-2014-03539
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2014

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: 03/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 02/25/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/15/2014; 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2012
• 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): Required Intervention
• Patient Age: 00029 YR