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

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Shipping Damage or Problem (1570)

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

Event Date 03/27/2015

Event Type  malfunction  

Event Description

It was reported that there was an out of box product failure.There was an impedance issue of a ??? error with electrode 3.The impedance check changed each time it was run failing on electrode 3.The impedance check was run multiple times including increasing pulse width and amplitudes, which still displayed a failure.The manufacturer representative even ran the impedance removing the operating room (or) lights from the field.The battery was removed and connected 3 times to ensure the connection was ok.The battery was removed and the lead was retested for motor responses.There was a response on all 4 electrodes; therefore a second battery was opened.The same process was followed to test the impedance of the new battery with continued impedance issues.Due to the failure of impedance it was determined to replace the lead.The new lead and the newest recent battery were implanted with successful impedance.The action required as a result of the event was that the device was not implanted.The diagnostic testing or trouble shooting performed was impedance testing and reprogramming.The product issue was resolved and it was unknown if the cause of the issue was determined.The lead and battery that were not used were mailed in on 2015-04-08.The patient status at the time of the report was alive with no injury.There were no patient symptoms or complications associated with the event.

Manufacturer Narrative

Concomitant products: product id: neu_wrench_acc, product type: accessory.Product id: 3058, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 3889-28, lot# va0tbg2, implanted: (b)(6) 2015, product type: lead.Product id: 3889-28, lot# va0tbpa, product type: lead.(b)(4).

Manufacturer Narrative

Analysis of the tined lead ((b)(4)) found no anomaly.(b)(4).

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: 4712154
• MDR Text Key: 5664151
• Report Number: 3004209178-2015-07594
• 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
• Report Date: 03/27/2015

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: 07/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 04/21/2015
• Supplement Dates Manufacturer Received: Not provided; 05/04/2015
• Supplement Dates FDA Received: 05/04/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2015
• 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 Age: 00065 YR