MAUDE Adverse Event Report: MEDTRONIC, INC. INTERSTIM; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 355018

Device Problems Break (1069); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

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

Event Date 03/17/2016

Event Type  malfunction  

Event Description

It was reported representative was in the or a day prior to this call and the physician notice a lead introducer kit was damaged, the "sheath almost split, bulging out, in the plastic part and could not get into the foreman." the representative reported she than opened another kit.The patient was reported doing fine.If additional information is received, a follow-up report will be submitted.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received indicated that there was no visible damage of the sheath or any other component in the introducer kit prior to using the device.The representative believed that the sheath almost split" during physician use but the physician stated the sheath was damaged prior to use.When looking at the sheath, it appeared enlarged in the area where the split was.The representative believed that physician unable to get into the foreman because the sheath was damaged during insertion.The kit was not returned.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5539556
• MDR Text Key: 41779187
• Report Number: 2182208-2016-00740
• Device Sequence Number: 1
• Product Code: GZB
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2016

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: 07/16/2017
• Device Model Number: 355018
• Device Catalogue Number: 355018
• Device Lot Number: W60234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided; 05/03/2016
• Supplement Dates FDA Received: 05/05/2016; 09/20/2017
• Date Device Manufactured: 10/01/2015
• 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: 00070 YR