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

Model Number 3550-18

Device Problems Bent (1059); Break (1069); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

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

Event Date 10/01/2014

Event Type  malfunction  

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.

Event Description

Meissnitzer, t., trubel, s., posch-zimmermann, r., meissnitzer, m.W.Ct-guided lead placement for selective sacral neuromodulation to treat lower urinary tract dysfunctions.Ajr.Am.J.Roentgenol.2015;205(5):1139-1142.Doi:10.2214/ajr.14.14270.Summary: selective sacral neuromodulation may fail after fluoroscopically guided lead placement because of malpositioning.We implemented a new technique to attain precise lead placement.Reported events: during the implantation of a sacral nerve stimulator (sns) in a (b)(6)-year-old woman for overactive bladder, the guidewire perforated the introducer sheath when advanced through the narrow sacral foramen.Ct imaging shows that the introducer sheath became deformed, and both had to be removed and repositioned.However, the authors noted that no unsuccessful lead placement attempts or failures were observed, and that they were ¿able to precisely place all the leads during the first attempt and distinctive responses to electrostimulation could be observed in all patients.¿ it was reported that all patients were implanted with interstim or interstim ii devices and components mentioned made it possible to deduce the model of lead introducer kit, but it was not possible to ascertain additional specific device information from the article or to match the reported event with any previously reported event.

Event Description

Additional information received from the author reported that the perforation of the introducer sheath occurred in (b)(6) 2014.The author stated that the altered anatomy of the sacrum with bony spurs and a long access path due to adipose constitution caused significant shear forces.Neither angulation nor back tension of the guidewire permitted advancement of the sheath over the wire.Forced advancement of the sheath caused its perforation.Therefore, an application error and not product failure was assumed by the author.

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 NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5721033
• MDR Text Key: 47291547
• Report Number: 3007566237-2016-02255
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3550-18
• Device Catalogue Number: 3550-18
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2016
• 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: 31 YR