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

Model Number 3058

Device Problems Break (1069); Unable to Obtain Readings (1516); Positioning Problem (3009)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 09/18/2014

Event Type  Injury  

Event Description

It was reported that there was normal battery depletion, an implantable neurostimulator (ins) change was planned, and during the procedure a lead revision was unsuccessful.There was a lead break or fracture, an impedance issue of a ¿???¿ error, and a gradual loss of therapeutic effect.Diagnostic testing and troubleshooting included impedance testing and x-rays.The product issue was not resolved and the cause of the issue was that the lead couldn¿t be placed in the patient with a 3.5 inch needle.The ins change was aborted, the lead and ins were explanted and a re-implant procedure was not completed because a 5 inch foramen needle wasn¿t available.There were no patient symptoms or complications associated with the event and the patient required hospitalization.The re-implant was scheduled for (b)(6) 2014.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 3093-28, lot # v476647, implanted: (b)(6) 2010, explanted: (b)(6) 2014, product type lead; product id 3037, serial # (b)(4), product type programmer, patient.(b)(4).

Event Description

Follow up information reported that the patient was doing well with the new lead and ins.If additional information is received, a follow up report will be sent.

• 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: 4164316
• MDR Text Key: 18545178
• Report Number: 3004209178-2014-19469
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

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: 11/28/2011
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 10/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2014
• Date Device Manufactured: 06/04/2010
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00032 YR