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

Model Number 3058

Device Problems High impedance (1291); Unable to Obtain Readings (1516)

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

Event Date 11/13/2014

Event Type  malfunction  

Event Description

It was reported that the implantable neurostimulator (ins) malfunctioned.The ins had high impedance of greater than 4000 ohms and had a ¿???¿ error and all electrodes had an impedance issue.The actions required as a result of the event were that the device was not implanted and a different product was used.The event occurred during the procedure and the ins with the impedance issue would be returned.Diagnostic testing or troubleshooting performed was impedance testing and they disconnected the lead from the ins, wiped it off, removed lights, and confirmed the implant depth.They tested off of the lead and the patient had positive motor responses.The product issue was resolved and the cause of the issue was not determined.There were no patient symptoms or complications associated with the event and the patient status was alive with no injury.

Event Description

Additional information received reported that the implantable neurostimulator (ins) was replaced on 2014-(b)(6) and the product was returned on 2014-(b)(6).

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_prog, serial# unknown, product type: programmer, physician.(b)(4).

Manufacturer Narrative

Analysis of the ins ((b)(4)) found no anomaly.

• 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: 4295656
• MDR Text Key: 5192390
• Report Number: 3004209178-2014-22537
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2014

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: 03/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/16/2014; 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2014
• 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: 00041 YR