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

Model Number 3058

Device Problem Unable to Obtain Readings (1516)

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

Event Date 10/06/2014

Event Type  malfunction  

Event Description

It was reported that during impedance testing at the implant procedure there was an impedance issue.Impedances for all case electrodes and unipolar pairs came back with ¿???¿.The implantable neurostimulator (ins) was inside the pocket during the event.The amplitude was increased to 2.0 and impedances were checked again.The lead was removed, wiped and reinserted into the header and checked again.The same error message appeared.As a result, the physician made the decision to not implant the device and used a different device.It was noted that the ins was to be returned to the manufacturer for analysis.There were no reported symptoms or complications associated with the event and the patient status at the time of report was noted as ¿alive ¿ no injury¿.No other details or an outcome was reported regarding this event.Additional information could not be obtained at the time of the report.Should additional be received a supplemental report will be filed.

Manufacturer Narrative

Concomitant product: product id neu_unknown_lead, lot# unknown, product type lead.(b)(4).

Event Description

It was reported the manufacturer representative hypothesized the impedance values were related to electrical work being performed in the neighboring room.All of the outlets were being replaced.They did not have issues outside of the electrical work timeframe.

Manufacturer Narrative

(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

Analysis of the interstim ii s/n: (b)(4) found no anomaly.

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: 4223016
• MDR Text Key: 4969846
• Report Number: 3004209178-2014-20889
• 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: 10/06/2014

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: 12/14/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 11/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 12/03/2014
• Supplement Dates FDA Received: 11/25/2014; 12/04/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2014
• 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: 00074 YR