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

Model Number 3058

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

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 309328, lot# 0203380719, explanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 309328, serial/lot #: 0203380719, (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from the consumer via a manufacturer representative (rep) reported that there was a broken lead during revision.There was a report that the patient had a lead change and some electrodes were left in patient.No further complications were reported/anticipated.Additional information received reported that there were no symptoms that the patient experienced related to the reported broken lead during revision.The cause of the broken lead during revision was reported to be difficulty removing/technique.There was a report that the broken lead during revision was not resolved.

Manufacturer Narrative

Product id: 309328, lot# 0203380719, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that there were no symptoms that the patient experienced related to the reported broken lead during revision.The cause of the broken lead during revision was reported to be difficulty removing/technique.There was a report that the broken lead during revision was not resolved.

• 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: 7515771
• MDR Text Key: 108306193
• Report Number: 3004209178-2018-10964
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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: 08/28/2016
• 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: 04/19/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 06/13/2018
• Date Device Manufactured: 03/02/2015
• 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 Outcome(s): Required Intervention