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

Model Number 3058

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Irritation (1941); Pain (1994); Headache, Lumbar Puncture (2186); Tooth Fracture (2428); Electric Shock (2554)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a health care professional via a manufacturer representative regarding a patient who was implanted with an implantable neuro stimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor it was reported that the patient lost a tooth today and patient believes it may be because she was jolted twice when her device was turned on.Patient later explained that right after the surgery the rep tried adjusting her system and twice she experienced severe shocks that went through her whole body, from her crotch to her head and the after the 2nd attempt patients body jumped a foot off of the bed.Patient said that her capped tooth fell off/that caused her to loose a tooth today and she is thinking that it was caused by the shocking.Patient said that the 3rd time rep was able to slowly adjust and currently at 0.7 patient said she has to get it fixed because it is her front tooth and it is irritating her lip patient said that the surgeon gave her dilaudid for the pain and a prescription for oral dilaudid however patient said that is out she is experiencing a headache on her left side and this morning her capped tooth fell out.Patient was redirected to follow up with her dentist.Patient said that her follow-up appointment with dr.(b)(6) is on thursday.No further complications were reported or anticipated.

Manufacturer Narrative

(b)(4) is no longer apply to this event so review of this , additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to death or serious injury or that the device in this report has malfunctioned.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.

• 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: 9271501
• MDR Text Key: 174623367
• Report Number: 3004209178-2019-20946
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

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: 12/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 01/24/2020
• Date Device Manufactured: 07/02/2019
• 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: 61 YR