MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Break (1069); Human-Device Interface Problem (2949); Material Twisted/Bent (2981)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: va1lbg2, implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 27-oct-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare professional (hcp) reported the lead fractured near the tine part during removal/explant of the implantable neurostimulator (ins) system.It was further reported that while the ins was extracted, the tip of the lead remained in the patient¿s body; the outer skin and electrode part remained in the patient¿s body.There was ¿no choice but to close the wound with the tip of the lead remaining in the body.¿ though it was noted the lead¿s core wire could be extracted, it was ¿presumed that a part remained in the patient¿s body.¿ after the procedure, no health injury to the patient was observed.As it was presumed the patient would undergo an mri at another facility in the future, the physician was asked to instruct the patient to bring their sacral neuromodulation (snm) identifying notebook.Further information received reported the patient¿s initial lead implant was ¿difficult and it was anxious.¿ when inserting the lead, ¿the tip was bent by the method of [the physician].¿ it was reportedly ¿unknown whether the shape of the sacral hold and the anatomical factors ahead of the sacral hole had an impact¿ on the implant.Ultimately, ¿it was considered that removal would be difficult when insertion was difficult.¿ it was noted the ¿patient¿s physique was large and the patient¿s fat was thick.At the time of removal, while confirming with the c-arm, tissue detachment was advanced by using a thin mosquito and it was picked with the same mosquito near the tine.When an attempt was made to remove it by pulling almost vertically, the event this time occurred.The shape when picking might have been pinpointed and applied load in the condition of lead and mosquito crossing.The shape of the equipment used must be considered as well.¿ the patient was scheduled to have the part removed on (b)(6) 2019.There were no further complications reported or anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 3889-28, lot#: va1lbg2, implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported the tined lead was broken during removal and that this resulted in unretrieved device fragments.It was noted the patient needed to undergo an mri, but because there was a ¿certain length of tined lead still left in the body,¿ it seemed that the patient would not be able to undergo an mri for this reason.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received reported that an explant surgery occurred on (b)(6) 2019 in order to address the lead piece that remained in the patient.The cause of the lead fracture was undetermined.There were no further issues reported as of (b)(6) 2019.There were no further complications reported or anticipated.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9146592
• MDR Text Key: 165030395
• Report Number: 3004209178-2019-18847
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• Date Device Manufactured: 01/17/2018
• 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
• Patient Age: 84 YR