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

Model Number 3058

Device Problem Compatibility Problem (2960)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that the implantable neurostimulator (ins) seemed to be ok the first year, but then it diminished in usefulness.The ins stopped working for the patient.He also had a brain injury and needed a mri, so the ins was removed.The patient outcome was not reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Product id 3037, serial# (b)(4); product type programmer, patient product id 3889-28, lot# v802403, implanted: 2011 (b)(6); product type lead.(b)(4).

Manufacturer Narrative

(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: 4220890
• MDR Text Key: 18798080
• Report Number: 3004209178-2014-20848
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2014

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: 03/28/2013
• 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: 12/11/2014
• Initial Date FDA Received: 11/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2014
• Date Device Manufactured: 10/11/2011
• 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): Required Intervention