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

Model Number 3058

Device Problems Unsealed Device Packaging (1444); Shipping Damage or Problem (1570)

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

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The manufacturer representative reported that the 3058 packaging was defective.The screw driver tip was looking through packaging ( contaminated).This was unacceptable to circulator.This was discovered prior to surgery and the implantable neuro stimulator (ins) was never implanted.The product was to be returned and replaced by a different product in the future.There was no patient involved in the event and the issue was resolved at the time of the event.Further follow-up is being conducted to obtain information.

Manufacturer Narrative

Evaluation summary: analysis of the ins s/n: <(><<)> (b)(4)> found that the tyvek seal was damaged by the tip of the wrench.The ins was received sealed in the new package.

Manufacturer Narrative

Conclusion code was updated.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5087009
• MDR Text Key: 26489600
• Report Number: 3004209178-2015-18210
• 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
• Type of Report: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• 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