MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Low Battery (2584)

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

Event Type  malfunction  

Event Description

It was reported that a device showed an impedance issue of a ¿???¿ error and the battery showed end of life.Diagnostic testing and troubleshooting included impedance testing.The issue was not resolved and the cause of the issue was not determined.The device was replaced.There were no patient symptoms or complications associated with the event.No outcome was reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id 3889-28, lot# va03e5d, implanted: (b)(6) 2013, product type lead; product id 3037, serial# (b)(4), product type programmer, patient; product id 3889-28, lot# va03e5d, implanted: (b)(6) 2013, product type lead.(b)(4).

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 4206009
• MDR Text Key: 4965196
• Report Number: 3004209178-2014-20493
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2014

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: 07/14/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2013
• 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: 00081 YR