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

Model Number 3058

Device Problem Device Inoperable (1663)

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

Event Type  Injury  

Event Description

It was reported the system was explanted approximately a week prior to the date of this report and hospitalization was also noted.The device was ¿not working¿ and was tested intra-operatively.No further information was provided.Further follow up is being conducted to obtain additional information.A follow up report will be sent if additional information is received.

Manufacturer Narrative

Concomitant product: product id 309328, serial # unknown, product type lead.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Analysis of the implantable neurostimulator found no anomaly.Analysis of the tined lead found that the #3 conductor was broken at the #3 electrode weld site 2.4 cm from the distal end.A functional test (electrodes to cut-off) of the lead showed that circuits #0-2 measured between 56.0-59.9 ohms.Circuit #3 was open.There were no shorts between circuits (dry).

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 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: 4323274
• MDR Text Key: 5135518
• Report Number: 3004209178-2014-23794
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2014

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: 11/28/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2014
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided; 12/22/2014
• Supplement Dates FDA Received: 12/23/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2013
• 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 Outcome(s): Hospitalization; Required Intervention