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

Model Number 3058

Device Problems Break (1069); Low Battery (2584); Device Or Device Fragments Location Unknown (2590)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 3093-33, lot# v271759, implanted: (b)(6) 2011, product type: lead.(b)(4) pertain to product id: 3093-33, lot# v271759 ,product type: lead.This device is included in the medical device correction, "unretreived device fragments models 3093 and 3889 interstim tined lea ds", educational brief/physician communication (december 2010).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's implantable neurostimulator (ipg) replaced.Lead partially removed.Lead broke when attempted to remove.Electrodes remain in body, but inactive.Replacement lead implanted on right side.New lead placed on left side.The patient indicators for use are for urinary dysfunction/sacral nerve stim.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported that the cause of the replacement was that the patient¿s implantable pulse generator (ipg) was depleted.It was noted that the partial lead was not left in the patient intentionally.No further complications were reported/anticipated.

Manufacturer Narrative

Corrected to reflect event type.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; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7264120
• MDR Text Key: 99856599
• Report Number: 3004209178-2018-03133
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2018

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: 01/14/2013
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 02/13/2018; 03/16/2018
• Supplement Dates FDA Received: 03/06/2018; 03/16/2018
• Date Device Manufactured: 07/15/2011
• 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: 59 YR