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

Model Number 355018

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Therapeutic Effects, Unexpected (2099); Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2014

Event Type  Injury  

Event Description

It was reported that during an implant procedure, the surgeon was unable to advance the dilator in the s3 foramen after receiving a response at 1.5 volts.Upon removing the needle, it was noticed that the end tip of the white sheath with the radio-opaque marker was missing.The procedure was repeated with a new dilator with the same result.An x-ray was performed to confirm.The surgeon tried the s2, s3, and s4 foramens on the left side and s2, s4 on the right side with either no/inappropriate response or not being able to insert the needle.The surgeon then made several attempts with differing needles and angles.The decision was made to abandon the case.It was stated that the surgeon wondered if the patient had previous sacral fractures/injury.There was noted s2 response from the left s4 needle placement, despite placing the needle in the ¿usual position.¿ the patient¿s status after removal was unknown.There was a patient injury noted by the potential of 2 radio-opaque markers being left in the patient.Please refer to mfg.Report # 3007566237-2014-02428, as the surgeon had an issue with both introducer sheaths and the case was aborted.

Manufacturer Narrative

Concomitant medical products: product id 355018, lot# w60118, implanted: (b)(6) 2014, product type: accessory.(b)(4).Analysis of the introducer found the sheath was torn and damaged.The marker band was not received for analysis.The dilators on both sheaths were able to be removed and inserted again without difficulty.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4048531
• MDR Text Key: 16172984
• Report Number: 3007566237-2014-02429
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2015
• Device Model Number: 355018
• Device Catalogue Number: 355018
• Device Lot Number: W60118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• 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