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

Model Number 3058

Device Problems Break (1069); Contamination (1120)

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

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3889, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient implanted with a neurostimulator.It was reported that the lead broke during the procedure while connecting the stimulator.It was noted that the patient was ok.It was also noted that the lead may have broken due to manipulation; the rep thought the lead broke by manipulation by fastening the screw too tight.After this event, the stimulator wasn't sterile anymore.A new lead and stimulator were implanted, and the issue was resolved.The patient was alive with no injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturing representative reported that they spoke with the implanting physician and the event was caused by manipulation while disconnecting from the old extension.There was no problem with material and the event was solved on the day it happened with a new electrode and stimulator.

Manufacturer Narrative

(b)(4).Analysis of the returned lead (lot # unknown) found that the proximal connector was pulled off/out.A distal and a proximal segment of the lead were received for analysis.No other segments were received.The proximal segment measured 0.4 cm and the distal segment measured 26 cm.Visual inspection of the lead segments revealed that a small part of the proximal end was stuck inside the connector port of the ins.Visual inspection of the conductors revealed that conductors were stretched, conductor coils were crushed, and conductors were cut.Visual inspection of the insulation revealed cosmetic environmental stress cracking (esc), cut through body insulation with the lead segmented, and melted outer insulation.Visual inspection of the electrode end revealed that the distal end was stretched.Visual inspection of the tines revealed that the radiopaque sleeve was crushed, some of the tines were folded back, and there was esc on the tines.Electrical testing determined that the continuity of the conductors was acceptable.There were no shorts observed between the conductors.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 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: 8497599
• MDR Text Key: 141394182
• Report Number: 3004209178-2019-07037
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Initial,Followup,Followup
• Report Date: 07/12/2019

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: 05/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 05/07/2019; 07/11/2019
• Supplement Dates FDA Received: 05/23/2019; 07/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2018
• 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
• Patient Age: 57 YR