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

Model Number 3058

Device Problems Break (1069); Failure to Interrogate (1332); Device Or Device Fragments Location Unknown (2590); Communication or Transmission Problem (2896)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_lead, lot# unknown, product type lead.

Event Description

Information received from a healthcare professional (hcp) via a manufacturer representative reported a consumer who had a lead fragment and might require an mri scan in the future.No symptoms were reported.It was noted there was partial lead fragment in-situ due to fracture after having whole system removal, for instance where tines and electrodes of the leads were not successfully removed.There were no further complications reported and/or anticipated.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 309328, lot# 0204012266, implanted: (b)(6)2011 explanted: (b)(6)2017, product type: lead.Correction: additional information received indicates that the correct mfg.Site id is 3004209178.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported the system was removed as the consumer had not used for 12 months prior and wished to have an mri.It was unknown if there were any symptoms related to the event.

• 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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6908303
• MDR Text Key: 89462940
• Report Number: 3007566237-2017-04144
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2017

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: 11/28/2011
• 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: 09/05/2017
• Initial Date FDA Received: 10/02/2017
• Supplement Dates Manufacturer Received: 11/07/2017; 11/06/2017
• Supplement Dates FDA Received: 11/07/2017; 12/06/2017
• Date Device Manufactured: 06/09/2010
• 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