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

Model Number 3058

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3889-28, lot# v796134, product type lead, (b)(4), pertains to the lead (v796134).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a consumer who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The hcp reported that the implantable neurostimulator (ins) was removed but the lead was left.The hcp noted that they did not have details as to the reason for implant removal or the hcp information.No further complications were reported or were expected.

Manufacturer Narrative

Information references the main component of the system and the other applicable components are: product id 3889-28 lot# v796134 product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a hcp.It was reported that the hcp didn't know what led to the lead being left in the patient, noting that they hadn't seen the patient since 2011.

• 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: 7019623
• MDR Text Key: 91792205
• Report Number: 3004209178-2017-23545
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

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: 02/14/2013
• 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: 11/09/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 12/11/2017
• Date Device Manufactured: 08/26/2011
• 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 Outcome(s): Required Intervention