MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Break (1069); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure, there was an impedance issue and a ¿???¿ error.There were consistently problems with the combinations of c+0-, c+1-, c+2-, and c+3-.The remaining combinations had appropriate impedance levels.Diagnostic testing and troubleshooting included impedance testing, x-rays, reprogramming, and additional impedance tests using a higher pulse width and amplitude.Different combinations of bipolar settings were checked to look for a bellows response and the lead was removed and reinserted into the implantable neurostimulator (ins).The issue was not resolved and the cause of the issue was not determined.The surgeon decided that a new ins should be implanted, the new ins impedances were within normal ranges, and the procedure was completed.The operating room time was increased by approximately 40 minutes and it was unknown if there were any patient symptoms or complications associated with the event.It was additionally reported that during the impedance testing, the ins was in the pocket when the ¿???¿ issues were seen.The surgeon had implanted 100 cases and this was the first time this had happened to him.There was concern about the system integrity and they were questioning whether the ins or lead was the issue.The patient was under anesthesia during the testing and the surgeon was concerned that the extended length of time in the operating room may increase risk of infection for the patient.Motor testing was done and demonstrated a threshold response that was higher than threshold previously.

Manufacturer Narrative

Concomitant medical products: product id 3037, serial# (b)(4), product type: programmer, patient; product id 3 889-33, lot# va0kyhy, implanted: (b)(6) 2014, product type: lead.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Upon device return, analysis for stimulator serial number (b)(4) found no anomalies.The returned stimulator was tested with a known good lead.The lead proximal end was connected to the stimulator, while the lead distal end and stimulator was submerged in a 0.9% saline solution.Using an clinician programmer, impedances were measured.Normal impedances were measured on all circuits and electrode pair combinations.

Manufacturer Narrative

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

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4023144
• MDR Text Key: 4845115
• Report Number: 3004209178-2014-15569
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 08/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/12/2014
• Supplement Dates FDA Received: 09/10/2014; 09/23/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2014
• 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
• Patient Age: 00045 YR