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

Model Number 3058

Device Problems Break (1069); Contamination (1120); High impedance (1291)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 309328, lot# b0985829k, implanted: (b)(6) 2011, explanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

The healthcare provider (hcp), via the manufacturer representative reported that an impedance test showed all electrode combinations being greater than 4,000 ohms.Due to this, the hcp decided to replace the lead with a new lead and then reconnect it to the original implantable neurostimulator (ins).During the procedure, when the hcp was working to mobilize the ins out of the pocket, the ins fell to the floor with a short section of the lead still present in the ins header block.It was stated the lead had just separated.The hcp later noted that they may have cut the lead with the scissors that they were holding and using to dissect the pocket.The lead was completely explanted.A new lead and ins were then successfully implanted.No further information was reported.A follow up report will be sent if additional information is received.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) found no significant anomaly.The ins was functionally okay.Analysis of the tined lead found no significant anomaly.The lead was cut through and segmented.

Manufacturer Narrative

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; ceiba norte industrial park, r; 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: 5043505
• MDR Text Key: 24650232
• Report Number: 3004209178-2015-17051
• 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: Physician
• Type of Report: Followup
• Report Date: 08/10/2015

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: 07/28/2011
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Supplement Dates Manufacturer Received: 09/15/2015
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2010
• 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
• Patient Outcome(s): Required Intervention